ThaiFDA Workshop K-Regulatory functions/marketing “Current ... · • ACTD (ASEAN Common...
Transcript of ThaiFDA Workshop K-Regulatory functions/marketing “Current ... · • ACTD (ASEAN Common...
ThaiFDA
byYuppadee JAVROONGRIT, Ph.D.
Assistant Director, Drug Control Division, FDA, ThailandThe 14th ICDRA
Raffles City Convention Centre, Singapore29 November 2010
Workshop K-Regulatory functions/marketing“Current Status and Future Perspective
for Mutual Recognitionin the context of ASEAN Collaboration”
ThaiFDA
• the ASEAN• collaboration• Mutual Recognition on Pharmaceuticals
Topics
ThaiFDA
• the ASEAN• collaboration• Mutual Recognition on Pharmaceuticals
Topics
ThaiFDA
total population ~ 580 million
- Brunei Darussalam- Cambodia- Indonesia- Lao PDR- Malaysia- Myanmar- Phillippines- Singapore- Thailand- Vietnam
AMSASEAN = Association of Southeast Asian Nations
Established --> 8 Aug. 1967Area --> 4.5 mill.Km2
ThaiFDA
The ASEAN- major Collaboration
ASEAN Summit
- Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation
The Leader (Presidents, Prime Minister)
Minister of Economic/Trade MinistryMinister of Foreign Affairs Ministry
ThaiFDA
• the ASEAN• collaboration• Mutual Recognition on Pharmaceuticals
Topics
ThaiFDA
The ASEAN- CollaborationASEAN Summit
Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation
WG1 - Mutual Recognition Arrangements (MRAs) & StandardsWG2 - Accreditation and Conformity Assessment Sub-WG - Scientific/Industrial Metrology
ACCSQ
ACC - ASEAN Committee on CosmeticPPWG - Pharmaceutical PWGEE PWG- Electrical and Electronic PWGPf PWG - Prepared Foodstuff PWGTMHS PWG - Traditional Medicine & Health Supplement PWGMedical Devices&Equipment PWGA PWG - Automotives PWGRB PWG - Rubber-based PWG…….
AWGPD – ASEAN Working Gr. on Pharmaceuticals Dev.…..
ThaiFDA
The ASEAN- CollaborationASEAN Summit
Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation
WG1 - Mutual Recognition Arrangements (MRAs) & StandardsWG2 - Accreditation and Conformity Assessment Sub-WG - Scientific/Industrial Metrology
ACCSQ
ACC - ASEAN Committee on CosmeticPPWG - Pharmaceuticals PWGEE PWG- Electrical and Electronic PWGPf PWG - Prepared Foodstuff PWGTMHS PWG - Traditional Medicine & Health Supplement PWGMedical Devices&Equipment PWGA PWG - Automotives PWGRB PWG - Rubber-based PWG…….
AWGPD – ASEAN Working Gr. on Pharmaceuticals Dev.…..Mutual
Recognition
ThaiFDA
• the ASEAN• collaboration• Mutual Recognition on Pharmaceuticals
Topics
ThaiFDA
The ASEAN- CollaborationASEAN Summit
Economic Cooperation-AEM - Political & Security Cooperation- Socio-cultural Cooperation
WG1 - Mutual Recognition Arrangements (MRAs) & StandardsWG2 - Accreditation and Conformity Assessment Sub-WG - Scientific/Industrial Metrology
ACCSQ
ACC - ASEAN Committee on Cosmetic
PPWG - Pharmaceuticals PWGEE PWG- Electrical and Electronic PWGPf PWG - Prepared Foodstuff PWGTMHS PWG - Traditional Medicine & Health Supplement PWGMedical Devices&Equipment PWGA PWG - Automotives PWGRB PWG - Rubber-based PWG…….
AWGPD – ASEAN Working Gr. on Pharmaceuticals Dev.…..Mutual
Recognition
ThaiFDA
ACCSQ/PPWG (1999-now)ASEAN Consultative Committee
for Standards and Quality / Pharmaceutical Product Working Group
Objective:to develop harmonization scheme of Pharmaceuticals regulations of the ASEAN member countries, to complement and facilitate the objective of AFTA, particularly, the elimination of Technical Barriers to Trade posed by the regulations, without compromising on drug quality, efficacy, and safety”
ThaiFDA
BA/BE Studies Malaysia
• ACTR : Quality IndonesiaSafety PhilippinesEfficacy Thailand
• ACTR-Guidelines : Analytical Validation Thailand
Process Validation SingaporeStability Study Indonesia
Chair country : MalaysiaCo-Chair country : Thailand
The PPWG– Lead country & Assignment (1)
ThaiFDA
Administrative & Glossary Malaysia• ACTD : Overall ACTD & ACTD Organization Thailand
Quality Indonesia
Clinical /Efficacy ThailandNon-Clinical Philippines
• IWG :Indonesia (Co-Chair)Singapore (Chair)
• MRA-BA/BE: Indonesia / Malaysia (Co-Chairs)
• MRA-GMP : Singapore / Malaysia (Co-Chairs)
• Post-marketing Alert System (PMAS): Singapore / Malaysia
The PPWG– Lead country & Assignment (2)
ThaiFDA
Comparative studyon Registration Requirement & Regulation
Agreement(ASEAN Harmonized Product, MRAs)
Identification the “Key Area on Requirements”for Harmonization
the Works -“Lead Countries”/Members
the Meetings
Implementation Capacity Building/Strengthening
Endorsement (ACCSQ / SEOM / AEM /…)
Working Scheme of the PPWG
- Tech. discussion gr.- Dialogue w/ Association - IWG- MRA Task forces - HOD- PPWG
Current Activities(1) Implementing ASEAN Har.products
- for new application - for existing Drug license (by 2012)
(2) Establishing GMP-MRA JSC(3) BA/BE MRA(4) Updating Tech.gls.(5) New ares of integration: Biological ,
Biotech., Biosimilar product(6) Facilitating the AEC (7) Coop.with international forum: WHO,
ICH, etc.
ThaiFDA
1. Harmonized Key Areas2. ACTR & ACTD & Technical guidelines3. Full implementation timeline4. MRA-GMP Inspection5. Vaccine chapter
The PPWG– Recognition & Agreement
6. on going tasks ;- MRA – BA/BE Testing- Variation guideline- updating the Technical guidelines : Q, S, E- training activities- new area of harmonization
ThaiFDAMutual Recognition (1)
ACTR, ACTD, Technical guidelines• ACTR (ASEAN Common Technical Requirement)• ACTD (ASEAN Common Technical Dossier)• Technical “Quality, Safety, Efficacy” guidelines -
- adopted guidelines (from WHO, ICH, and International pharmacopoeia)- newly developed ASEAN Quality guidelines;
(1) Analytical Validation guideline(2) BA/BE Studies guideline(3) Process Validation guideline(4) Stability Study guideline
ThaiFDA
adopted 15 ICH-Safety gl.
S&E Technical guidelineGuideline - Safety
Guideline - Efficacy
adopted 11 ICH-Efficacy gl. (E1, E2A, E2C, E3, E4, E6-11)
accepted as Ref.gl. 4 ICH-Efficacy gl. (E2C(A), E2D, E2E, E12A)
ThaiFDA
ACTRA set of Written Materials
intended to guide applicants to prepare application dossiers
in a way that is consistent with the expectations of
all ASEAN Drug Regulatory Authorities
ACTDThe part of
marketing authorization application dossier that is common to
all ASEAN member countries
ThaiFDA
No. Parameter ComponentsRequirement *
NCE Bio. MaV MiV GP
Rt. S/P Ind.
Note: * = all studies should be complied to ICH Guidelines on Efficacy (current are E1-E12)NCE = New Chemical Entity
Bio. = Biotechnological productMaV = Major Variation (variation affecting 1 or MORE of following aspect: Rt., S/P, Ind., or other Non-MiV)
- Rt. = Route of Adminstrative- S/P = Strength & Posology- Ind. = Indication
MiV = Minor Variation (variation not affecting 1 or MORE of following aspect: Rt., S/P, Ind., API)GP = Generic Product
Format of ACTR
ThaiFDA
* = upon request
Format of ACTD
Part I
TOCAdmin.data / Product Info.
Part IIQuality
Overall Summary& Report
Part IIINon-Clinical
Overview,Summary,
& Study Report *
Part IVClinical
Overview,Summary,
& Study Report*
ThaiFDA
ACTR - Quality
Drug Substance - General info.- Manufacture - Characterisation- Control of Drug Substance- Ref. Std. or Materials- Container Closure System- Stability
Drug Product - Description and Composition- Pharmaceutical Development- Manufacture- Control of Excipients- Control of Finished Product- Ref. Std. or Material - Container Closure System- Stability - Product Interchangeability
Equivalence evidence
ThaiFDA
ACTR - Safety
Pharmacology - Primary P’dynamics- Secondary P’dynamics- Safety P’cology- P’dynamic Drug Interaction
Toxicology - Single Dose Toxicity- Repeat Dose Toxicity- Genotoxicity- Carcinogenicity- Reproductive & Development ToxicityPharmacokinetics
- Absorption- Distribution- Metabolism (inter-species comparison)- Excretion- P’cokinetic Drug Interaction
(Non-clinical)- Other P’cokinetic Studies
Local Tolerance
Other Toxicity Studies
List of Key Literature Ref.
ThaiFDA
ACTR - Clinical Data
BA & BE Studies- BA Studies- Comparative BA or BE Studies
Human P’cokinetic Studies
Studies Pertinent to P’cokinetics Using Human Biomaterials
Human P’codynamic Studies
Efficacy and Safety
Post Marketing Data (if available)
References
ThaiFDA
Part 1: TOC Admin.Data&Product Info.Section A: IntroductionSection B: Overall ACTD-ToCSection C: Doc. Required for Registration
Part 2 : Quality DocumentSection A: ToCSection B: Quality Overall SummarySection C: Body of Data
Part 3 : Non-clinical Document
Section A: ToCSection B: Non-clinical OverviewSection C: Non-clinical Written & Tabulated Summaries
1. ToC2. Pharmacology3. Pharmacokinetics4. Toxicology
Section D: Non-clinical Study Reports1. ToC2. Pharmacology3. Pharmacokinetics4. Toxicology
Part 4 : Clinical Document
Section A: ToCSection B: Clinical OverviewSection C: Clinical Summaries
1. Summary of Biopharm & Associated Analytical Methods
2. Summary of Clinical Pharmacology Studies3. Summary of Clinical Efficacy4. Summary of Clinical Toxicology5. Synopses of Individual Studies
Section D: Tabular Listing of All Clinical StudiesSection E: Clinical Study ReportsSection F: List of Key Literature References
Content of ACTD
ThaiFDA
• starting - 2005• goal - ASEAN Sectoral MRA on GMP Inspection
- signed by AEM- Apr.2009• working area ;
- Code of GMP Standards (PIC/S, or equivalence)- Quality System of GMP’s Inspection Unit (PIC/S quality requirement)- GMP Inspection System & Report
• the MRA ;- on Pharmaceuticals Product, not Bio./Radio/CT materials- recognition GMP Certificate & GMP Inspection Report for product registration- on principle “ASEAN+2”- establishment of Joint Sectoral Committee (JSC)
- assessment Competency of GMP Inspection Unit (Gov. org.)- listing the Recognized GMP Inspection Unit (of AMS)
Mutual Recognition (2)MRA– GMP Inspection
ThaiFDA
• starting - 2005• goal - ASEAN Sectoral MRA on BA/BE Studies Report• working area ;
- Comparator product (definition, decision tree, selection, list)- Accreditation of BA/BE Centres (criteria for audit/inspection, certification)- Standards on GCP & GLP- Framework for mutual acceptance of BA/BE Study Report
• the MRA ;- mutual acceptance of BA/BE Study Report
Mutual Recognition (3)MRA– BA/BE Study Report
on going !
ThaiFDA
• to facilitate AFTA & AEC• to eliminate Technical Barrier to Trade (TBT)• to align to International Standards• without compromising on Quality, Safety, Efficacy of
Pharmaceuticals
The PPWG– Recognition & Agreement
Product License
the Decisionof individual Member Country
ThaiFDA
Together !!!Thank You ...