Dr Nishodh Saxena

30th March 2013

Regulatory Affairs

What is the product

Is the quality presented acceptable on grounds of safety and

efficacy

Is the quality presented reproducible

How long can the quality be maintained

Quality must ensure consistency of safety and efficacy during the shelf life of all

batches produced

Data in the dossier should enable us to answer

the following questions

Requirements of Documents for Marketing Authorization in INDIA

1 Duly filled and signed form as per the requirement

2 Copy of the challan of Fee paid

3 Land possession document

4 List of Directors

5 Memorandum of article of association

6 Authority letter for authorized signatury

7 Copy of the form 46 (approval of CT)

8 Copy of the approved plant layout

9 Site Master File

10Copy of NOC of Pollution control board

11Water system P amp I diagram

12HVAC details and Area qualification report

13Process flow chart

14List of SOPs

15Specification

16Copy of approval and contract of Waste disposal

Requirements of Documents for Marketing Authorization in INDIA

17 List of equipments for Manufacturing

18 List of equipments for Quality Control

19 List of Products in 6 copies

20 Draft Label

21 List of Technical Staff

22 Any other document as required eg Inspection report

Compliance report Check compliance report CoAs Undertaking

etc

Commonly used forms as per D amp C Act 1940

1 Form 24 Application for products of C C (1) and X

2 Form 25 License C C (1) and X

3 Form 27 Application for products excluding C C (1) and X

4 Form 28 License for products excluding C C (1) and X

5 Form 29 License for purpose of examination test or analysis

6 Form 30 Application for purpose of examination test or analysis

7 Form 35 Inspection book

8 Form 46 Permissionapproval for manufacture of New Drug

Formulation

Track sheet for the documents required for filling and approvals

1 Product-Brand

2 Product-Generic

3 Npd Form for the country

4 IDR Proof

5 DCI-Domestic

6 NOC-Export

7 Mfg Lic

8 COPP

9 BMR

10BPR

11RM SpecSTP

12FP SpecSTP

13PM SpecSTP

14RM COA

15FP COA

16API COA

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

What is the product

Is the quality presented acceptable on grounds of safety and

efficacy

Is the quality presented reproducible

How long can the quality be maintained

Quality must ensure consistency of safety and efficacy during the shelf life of all

batches produced

Data in the dossier should enable us to answer

the following questions

Requirements of Documents for Marketing Authorization in INDIA

1 Duly filled and signed form as per the requirement

2 Copy of the challan of Fee paid

3 Land possession document

4 List of Directors

5 Memorandum of article of association

6 Authority letter for authorized signatury

7 Copy of the form 46 (approval of CT)

8 Copy of the approved plant layout

9 Site Master File

10Copy of NOC of Pollution control board

11Water system P amp I diagram

12HVAC details and Area qualification report

13Process flow chart

14List of SOPs

15Specification

16Copy of approval and contract of Waste disposal

Requirements of Documents for Marketing Authorization in INDIA

17 List of equipments for Manufacturing

18 List of equipments for Quality Control

19 List of Products in 6 copies

20 Draft Label

21 List of Technical Staff

22 Any other document as required eg Inspection report

Compliance report Check compliance report CoAs Undertaking

etc

Commonly used forms as per D amp C Act 1940

1 Form 24 Application for products of C C (1) and X

2 Form 25 License C C (1) and X

3 Form 27 Application for products excluding C C (1) and X

4 Form 28 License for products excluding C C (1) and X

5 Form 29 License for purpose of examination test or analysis

6 Form 30 Application for purpose of examination test or analysis

7 Form 35 Inspection book

8 Form 46 Permissionapproval for manufacture of New Drug

Formulation

Track sheet for the documents required for filling and approvals

1 Product-Brand

2 Product-Generic

3 Npd Form for the country

4 IDR Proof

5 DCI-Domestic

6 NOC-Export

7 Mfg Lic

8 COPP

9 BMR

10BPR

11RM SpecSTP

12FP SpecSTP

13PM SpecSTP

14RM COA

15FP COA

16API COA

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Requirements of Documents for Marketing Authorization in INDIA

1 Duly filled and signed form as per the requirement

2 Copy of the challan of Fee paid

3 Land possession document

4 List of Directors

5 Memorandum of article of association

6 Authority letter for authorized signatury

7 Copy of the form 46 (approval of CT)

8 Copy of the approved plant layout

9 Site Master File

10Copy of NOC of Pollution control board

11Water system P amp I diagram

12HVAC details and Area qualification report

13Process flow chart

14List of SOPs

15Specification

16Copy of approval and contract of Waste disposal

Requirements of Documents for Marketing Authorization in INDIA

17 List of equipments for Manufacturing

18 List of equipments for Quality Control

19 List of Products in 6 copies

20 Draft Label

21 List of Technical Staff

22 Any other document as required eg Inspection report

Compliance report Check compliance report CoAs Undertaking

etc

Commonly used forms as per D amp C Act 1940

1 Form 24 Application for products of C C (1) and X

2 Form 25 License C C (1) and X

3 Form 27 Application for products excluding C C (1) and X

4 Form 28 License for products excluding C C (1) and X

5 Form 29 License for purpose of examination test or analysis

6 Form 30 Application for purpose of examination test or analysis

7 Form 35 Inspection book

8 Form 46 Permissionapproval for manufacture of New Drug

Formulation

Track sheet for the documents required for filling and approvals

1 Product-Brand

2 Product-Generic

3 Npd Form for the country

4 IDR Proof

5 DCI-Domestic

6 NOC-Export

7 Mfg Lic

8 COPP

9 BMR

10BPR

11RM SpecSTP

12FP SpecSTP

13PM SpecSTP

14RM COA

15FP COA

16API COA

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Requirements of Documents for Marketing Authorization in INDIA

17 List of equipments for Manufacturing

18 List of equipments for Quality Control

19 List of Products in 6 copies

20 Draft Label

21 List of Technical Staff

22 Any other document as required eg Inspection report

Compliance report Check compliance report CoAs Undertaking

etc

Commonly used forms as per D amp C Act 1940

1 Form 24 Application for products of C C (1) and X

2 Form 25 License C C (1) and X

3 Form 27 Application for products excluding C C (1) and X

4 Form 28 License for products excluding C C (1) and X

5 Form 29 License for purpose of examination test or analysis

6 Form 30 Application for purpose of examination test or analysis

7 Form 35 Inspection book

8 Form 46 Permissionapproval for manufacture of New Drug

Formulation

Track sheet for the documents required for filling and approvals

1 Product-Brand

2 Product-Generic

3 Npd Form for the country

4 IDR Proof

5 DCI-Domestic

6 NOC-Export

7 Mfg Lic

8 COPP

9 BMR

10BPR

11RM SpecSTP

12FP SpecSTP

13PM SpecSTP

14RM COA

15FP COA

16API COA

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Commonly used forms as per D amp C Act 1940

1 Form 24 Application for products of C C (1) and X

2 Form 25 License C C (1) and X

3 Form 27 Application for products excluding C C (1) and X

4 Form 28 License for products excluding C C (1) and X

5 Form 29 License for purpose of examination test or analysis

6 Form 30 Application for purpose of examination test or analysis

7 Form 35 Inspection book

8 Form 46 Permissionapproval for manufacture of New Drug

Formulation

Track sheet for the documents required for filling and approvals

1 Product-Brand

2 Product-Generic

3 Npd Form for the country

4 IDR Proof

5 DCI-Domestic

6 NOC-Export

7 Mfg Lic

8 COPP

9 BMR

10BPR

11RM SpecSTP

12FP SpecSTP

13PM SpecSTP

14RM COA

15FP COA

16API COA

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Track sheet for the documents required for filling and approvals

1 Product-Brand

2 Product-Generic

3 Npd Form for the country

4 IDR Proof

5 DCI-Domestic

6 NOC-Export

7 Mfg Lic

8 COPP

9 BMR

10BPR

11RM SpecSTP

12FP SpecSTP

13PM SpecSTP

14RM COA

15FP COA

16API COA

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Track sheet for the documents required for filling and approvals

17 AMV-FP

18 PVPPVR

19 Stability Acc Study data

20 Stability Real Time Study data

21 BEBA or CT Report

22 FP Samples

23 API Open Part DMF

24 FP Chromatogram

25 API Chromatogram

26 Working Standard

27 Literature

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

International Conference of Harmonization (ICH)

bull European Union

bull USA

bull Japan

The ICH countries developed a common format for submissions of

new marketing authorization applications (MAAs) CTD format

Non-ICH countries covers all countries outside ICH includes also

Canada Switzerland Australia and ASEAN

ICH Non-ICH countries

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

ASEAN Association of South-East Asian Nations

Population 500 millions

Member countries (10)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Common Wealth if Independent States (CIS countries)

Member countries (11+1)

1 Russia

2 Ukrain

3 Kazakhastan

4 Belarus (Head Quarter)

5 Uzbekistan

6 Turmenistan (associate member)

7 Azerbaijan

8 Georgia

9 Armenia

10 Kyrgyzstan

11 Tajakistan

12 Moldova

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

RoW (Rest of the World)

RoW is Rest of the World excluding

UK USA Other Euro American Countries (OEAC) including

Australia New Zealand amp Canada

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

ICH-CTD Dossier

Complete ICH CTD dossier requested for ICH countries and some Non- ICH

countries (like Canada Switzerland Australia Croatia)

Organization of ICH-CTD

ICH-CTD dossier (Module 1 2 3 4 and 5)

Module 1 Administrative documents Labeling texts and mock-ups

Module 2 Overviews and Summaries

Module 3 Quality Data

Module 4 Preclinical Data

Module 5 Clinical Data

General requirements for marketing authorization application for

Biosimilars ndashICH-CTD

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

ASEAN Association of South-East Asian Nations non-ICH countries

A-CTD Dossier

For Market Authorization in ASEAN Dossier is filed mainly in A-CTD format

Organization of A-CTD

A-CTD dossier (Part I II III and IV)

Part I Administrative Information

Part II Quality Document

Part III Preclinical Safety Document

Part IV Clinical Efficacy Document

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

ASEAN Status of ACTD Implementation

For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

ASEAN Association of South-East Asian Nations

Main differences are the organization of data and the numbering of sections

Organization of A-CTD ASEAN-CTD and ICH-CTD

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Quality Part contains all the data related to Drug Substance (DS) and Drug

Product (DP) with complete details but basic contents remains the same for

both

Organization of A-CTD ASEAN-CTD and ICH-CTD

ASEAN-CTD

Part II

Quality Summary

amp

Body of Data

ICH-CTD

Module 2

Quality Overall Summary

Module 3

Quality

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

ICH-CTD Module 3

Module 3

31 MODULE 3 TABLE OF CONTENTS

32 BODY OF DATA

32S DRUG SUBSTANCE

32S1 General Information

32S2 Manufacture

32S3 Characterisation

32S4 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P DRUG PRODUCT

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Module 3 (Cont)

32A APPENDICES

32A1 Facilities and Equipment

32A2 Adventitious Agents Safety Evaluation

32A3 Novel Excipients

32R REGIONAL INFORMATION

33 LITERATURE REFERENCES

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Section C Body of Data

S DRUG SUBSTANCE

S 1 General Information

S 11 Nomenclature

S 12 Structural formula

S 13 General Properties

S 2 Manufacture

S 21 Manufacturer(s)

S 22 Description of Manufacturing Process and Process Controls

S 23 Control of Materials

S 24 Controls of Critical Steps and Intermediates

S 25 Process Validation andor Evaluation

S 26 Manufacturing Process Development

S 3 Characterization

S 31 Elucidation of Structure and Characteristic

S 32 Impurities

S 4 Control of Drug Substance

S 41 Specification

S 42 Analytical Procedures

S 43 Validation of Analytical Procedures

S 44 Batch Analyses

S 45 Justification of Specification

S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

Stability Summary and Conclusion

Post-approval Stability Protocol and Stability

Commitment

Stability Data

A-CTD Part II Section C (DRUG SUBSTANCE)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

P DRUG PRODUCT

P 1 Description and Composition

P 2 Pharmaceutical Development

P 21 Information on Development Studies

P 22 Component of Drug Product

P 221 Active Ingredients

P 222 Excipients

P 23 Finished Product

P 231 Formulation Development

P 232 Overages

P 233 Physicochemical and Biological Properties

P 24 Manufacturing Process Development

P 25 Container Closure System

P 26 Microbiological Attributes

P 27 Compatibility

P 3 Manufacture

P 31 Batch Formula

P 32 Manufacturing Process and Process Control

P 33 Controls of Critical Steps and Intermediates

P 34 Process Validation andor Evaluation

P 4 Control of Excipients

P 41 Specification

P 42 Analytical Procedures

P 43 Excipients of Human and Animal Origin

P 44 Novel Excipients

P 5 Control of Finished Product

P 51 Specification

P 52 Analytical Procedures

P 53 Validation of Analytical Procedures

P 54 Batch analyses

P 55 Characterization of Impurities

P 56 Justification of Specification

P 6 Reference Standards or Materials

P 7 Container closure system

P 8 Product Stability

Stability Summary and Conclusion

Post-approval stability protocol and stability

commitment

Stability Data

P 9 Product Interchangeability

Section D Key Literature References

A-CTD Part II Section C (DRUG PRODUCT)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

bull API specification as per EP

bull STP of DS as per specification

Data required for Dossier filing of Drug Substance (DS) in Myanmar Vietnam

For Dossier filing in Myanmar only Drug Substance Specification and Analytical

Procedures are required Method Validation is not required

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

1048708 Special documents requested

Appendix 8 Singapore Quality Overall Summary for Biologic

Validation sheet

Singapore Stability sheet

Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 EU approval letters

1048708 EU Assessment Reports (from benchmarking countries)

1048708 TGA approval letters if available

1048708 Patent declaration form

1048708 COAs of DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In Singapore (ASEAN)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

1048708 Plant Master File registration required before MAA can be submitted

1048708 Administrative documents eg

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 COAs of DS and DP

1048708 Batch Records requested for DP

1048708 Detailed information about quality part requested even very

confidential information

Additional documents required by the Regulatory agency for Dossier

Filing In Taiwan (ASEAN)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

1048708 Detailed information about quality part requested even very confidential

information

1048708 Administrative documents eg

1048708 Application Forms

1048708 CPP

1048708 GMP certificates

1048708 Letter of authorizations (Power of Attorneys)

1048708 Labeling documents

1048708 SOPs for test methods

1048708 COAs of DS and DP

1048708 Only one manufacturer can be registered for DS and DP

Additional documents required by the Regulatory agency for Dossier

Filing In China (ASEAN)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Important web sites

DCGI-CDSCO httpwwwcdsconicin

DCGI Guidelines httpwwwgooglecomhl=enampsclient=psy-

abampq=dcgi+guidelines+pdfampoq=DCGI+ampgs_l=hp130l42586177697349540001185610j5

50001c17psy-

ab3rAuntWOcwUamppbx=1ampbav=on2orr_qfampbvm=bv44442042dbmkampfp=670e618efc243f0dampb

iw=1280ampbih=923

eg

cdsconicinCDSCO-GuidanceForIndustrypdf

wwwcdsconicinGuidance_for_New_Drug_Approval-23072011

WHO httpwwwwhointen

ICH wwwichorg

US-FDA wwwfdagov

CHMP wwwemaeuropaeuemaindexjspcurl=pagesabout_usjsp

MHRA wwwmhragovuk (Medicines and Healthcare products Regulatory Agency)

EMA wwwemaeuropaeu

TGA wwwtgagovau ( Therapeutic Goods Administration Australias)

Thanks

Contact details Phone 9824443676

Mail ID nishodhsaxenayahocom

Profile inlinkedincomindrnishodhsaxena