KAPIHAN AT TALAKAYAN - ww2.fda.gov.ph Kapihan - 04... · •Revision to AO 56 s. 1989, licensing of...

Republic of the Philippines Department of Health

Food and Drug Administration

KAPIHAN AT TALAKAYAN

CENTER FOR DRUG REGULATION AND RESEARCH

04 December 2014 FDA Main Building

1. Organizational Structure

2. CDRR Activities

3. Advocacy on Transparency

4. Updates on Regulations

5. Regulatory Challenges

6. Commitments

7. Way Forward

Presentation Outline

2



ORGANIZATIONAL STRUCTURE

3

CENTER DIRECTOR

LICENSING AND REGISTRATION

DIVISION

Manufacturers

/ Traders

Licensing

Distributors/ Retail Outlets

Licensing

LABORATORY SUPPORT DIVISION

5

Pharma/ Human

Drug Registration

Veterinary Drug

Registration

Vaccines and

Biologicals Registration

Clinical Trial

Evaluation

PMS Section

STANDARDS DEVELOPMENT

Section

CLINICAL RESEARCH

Section

PRODUCT RESEARCH AND STANDARDS

DEVELOPMENT DIVISION

CDRR MANPOWER COMPLEMENT

Total CDRR

personnel

Technical

Personnel

Non

technical

Personnel

92 63 29

6



7

CDRR ACTIVITIES

17 November 2014 Opening Ceremony and Forum

JY Campos Hall A, Bayanihan Center, Pioneer St., Brgy. Kapitolyo, Pasig City

8

National Consciousness

Week against Counterfeit Medicines

17 November 2014 Forum and Opening ceremony

Objectives

• Discuss the global and local perspectives on Counterfeit Medicines (International organization, local and multinational pharmaceutical industry)

• Impact of Counterfeit Medicines on Public Health Safety (Consumer and Medical Healthcare Perspectives)

• Consumer awareness: Media Roundtable and Discussion

9

Media Roundtable Luncheon • 9TV

• Abante

• Business Mirror

• CNN

• DZRH

• DZXL

• IBC 13

• Light network

10

• Malaya

• Manila Times

• Net 25

• Philippine Daily Inquirer

• PNA

• Reuters

• TV5

• UNTV

Media Roundtable Luncheon

11

17 November 2014 Opening Ceremony on JY Campos Hall A,

Bayanihan Center, Pioneer St., Brgy. Kapitolyo, Pasig City

Insights

• There is a need to raise awareness at all levels. Maximize the use of internet and the media, engage the academe

• There should be an improved patient/ consumer/ healthcare provider/industry and regulator communication and collaboration

12

18 November 2014 Seminar for Law Enforcement Groups

13


Objectives

• Learn the routes, pathways, sources of counterfeit medicines from international experts

• Share experiences and challenges in the enforcement and prosecution of cases of Counterfeit Medicines

• Identify the barriers in effective inter-agency collaboration

14


Insights

• Process of collection, monitoring, and enforcement must be streamlined

• Policy gaps and judicial platform for enforcement must be addressed and aligned

• Inter-agency collaboration must be strengthened

• Effective communication between the government agencies is a must

15

19 November 2014 FDA Alabang

Highlights:

• Launch of Coalition for Safe Medicines

• Launch of Pharmaceutical Transparency through Technology

• Awarding of Poster-making Contest Winners

• Pledge of commitment from government agencies , organizations, schools

16

17

Coalition for Safe Medicines

Poster-making contest winners

18

We recognize that there is a need…

To create an anti-counterfeit stakeholder group to spearhead and initiate action agenda towards safer medicines by acting against Substandard, Spurious, Falsely Labelled, Falsified, and Counterfeit (SSFFC) medical products.

19

Pledge of commitment

20

21

PNP CIDG AFFCU

PCTC IPOPhl FDA

PACOP PSHP PPhA

DOH League of Pharmacists

MeTA Philippines Health Sector

Catalyst

USP PQM

Manila Pharmacists

Society 22

PCPI PHAP PPMA PAPPI

23

24

19 November 2014 FDA Alabang

20-21 November 2014

• The FDA clusters of the DOH regional offices headed by the FROO regional cluster heads carried out activities in the respective provinces.

25



Advocacy on Transparency

26

Good Regulatory Practice

• CDRR-FDA’s guidance in policy formulation

27

Consultation Process

Drafting of Policies at the Center Level

↓

Small/Focus Group Discussion

↓

Review and Revision

↓

Public Consultation 28

Transparency and Feedback

1. The consultation shall be recorded (media and transcription)

2. Minutes and presentations shall be provided along with all other references and materials

3. Stakeholders’ responsibility to disseminate information to others

4. Should there be a need for another consultation, FDA shall call for another meeting

5. Revised draft prior to public hearing shall be posted

29

Transparency and Feedback

30

Transparency Advocacy

31


32


33

LATEST DECKING SCHEDULE

34

PRODUCT SCHEDULE

Initial AUG 2013

Monitored Release AUG 2013

Automatic Renewal OCT 2014

Renewal FEB 2014

Monitored Release Extension MAR 2014

PCPR OCT 2014

CLIDP OCT 2014

Revalidation UPDATED

Variation (RRS) JUN 2014

Variation (SLE-SC) JUN 2014

Variation (MiV-PA02) JUL 2014

Variation (MiV-N01-10) AUG 2014

Compliance JUNE 2014

PROMO UPDATED

Certification UPDATED

GLE UPDATED

Vaccine Group AUG 2014

Veterinary Group MAY 2014



UPDATES ON REGULATIONS

35

• Administrative Order – 2

• FDA Circular – 8

• FDA Memorandum Circular – 3

2014 Issued Regulations

36

Administrative Order No. 2014-0016 (1)

37

Administrative Order No. 2014-0016

• Biosimilars Registration via ACTD

• Comparability exercises as proof of similarity instead of full clinical and non-clinical data

38

Administrative Order No. 2014-0034 (2)

39


• Revision to AO 56 s. 1989, licensing of drug establishments

• Notable changes:

Licensing of CROs and Sponsors, institutional pharmacies

New classification/grouping of establishments (DM, DD, DS, RONPDs, CROs, Sponsors) 40




Coverage to include LGUs

Implementation of RMP reqt

IEC display reqts

Pharmacy compounding 41




Waiving of pre-opening inspection for certain establishments

Validity (2 yrs for initial, 3 yrs for renewal)

Variations 42

FDA Circular No. 2014-006 (1)

43


• Issuance of Certification for minor variations for LTO

44


45


• Implementation of ASEAN Variation Guidelines

• Incorporation of country specific PACs

• Issuance of certifications

• Introduction of Notification

46


47


• Sale and distribution of empty gelatin capsules is not allowed for drug outlets

48


49


• Sharing of experience from practitioners, clinicians, researchers regarding the application of stem cell therapy for corneal resurfacing with limbal stem cells

50


51


• Reiteration: TM products ( traditional Chinese, Ayurvedic, Homeopathic) are drugs

• Manufacturers, distributors, retailers – must secure LTO

• TM must be registered

52


53


• IRR for Foreign GMP Clearance and Inspection of Foreign Drug Manufacturers

• Requirement for registration of imported products

54

FDA Circular No. 2014-018 and amendment (7-8)

55


56


• Hospital establishments manufacturing medical-grade oxygen

• LTO and CPR requirements

57

FDA Memorandum Circular No. 2014-001 (1)

58


• Submission of e-copies of registered drug products’ dossier

59


60


• New LTO format

61


62


• Display of AMR Infomercial for outlets with audio-visual displays

63

Target Regulations

64

1) Revised AO on Pharmacovigilance

2) Registration of Clinical Trials

3) Labeling Requirements

4) New Registration Requirements

5) Combination Products/Kits

6) RMP on Drug Products

Target Regulations 65

7) Exemption from Lot Release

8) ACTR Implementation on all Drug Products

9) Blood and Blood Products Regulation

10) Physician Samples

11) Fixed Dose Combination

12) Homeopathic Product Registration

Target Regulations 66

Target Regulations

13) Compassionate Special Permit

14) Radiopharmaceuticals

15) Expedited Review of Pre-qualified Vaccines

16) Donations

17) Registration of Veterinary Drug Products

67

Target Regulations

18) RMP on Drug Establishments

19) Licensing of Hospital Manufacturers (Radiopharmaceuticals and Medical Oxygen)

20) Revision of BC 8 s. 2001 (Product Recall)

21) Fees and Charges

22) Registration of Medical Oxygen

22) Compounding Pharmacy

23) Licensing of LGUs

68



69

REGULATORY CHALLENGES

Challenges

1. Misalignment of HR with expected regulatory workload and output

2. Increased demand for training and advocacy given the effects of harmonization and globalization

3. Influx of imported generic medicines w/o overseas GMP audit

4. Increased demand for administrative and logistical support to operations

– Lack of resources

– Needs stronger IT infrastructure

70

Major Deficiencies Encountered

Noncompliance to AO 2013-0021 (ACTD/ACTR Adoption):

• Not in ACTD/ICH-CTD Format

• Lacking Part (I, II, III, or IV)

71

Other Deficiencies Encountered

Noncompliance to FMC 2013-033 and FMC 2014-001 (Conversion to E-copy), and Memorandum on E-copy submission for compliance, revalidation, and re-applications:

• Corrupted files

• Empty folders

• Failure to submit e-copy of old files

72


1. Conversion to PCPR encoded as Initial

2. MR to Initial, encoded as pure MR

3. Renewal encoded as initial

4. Amendment (change in status from For Export Only to local, labelling change) encoded as initial

5. Application of PCPR + CLIDP in 1 DTN

6. MRE encoded as MR

73


7. Encoded as MR (Initial application)

8. Encoded as Initial (MR application)

9. Wrong dosage strength

10. Wrong classification (HR but encoded as Rx)

11. Wrong pharmacologic category

74



75

COMMITMENTS

Commitments

1. Update existing regulations to align with international standards and practices

2. Act on all incoming requests within the committed turn-around time

3. Intensify post-market surveillance through compliance monitoring and pharmacovigilance

4. Conduct trainings for QPIRA and licensing of establishments

76



77

WAY FORWARD

1. International Collaboration • Collaboration with other DRAs (Trainings, GMP Audits, Dossier

Evaluations)

• PIC/S Accession

• PPWG/TMHS

• ICDRA

2. Work Process Improvement • Risk-based approach on drug evaluation, GMP inspection and

certification, QC testing, and PMS

• Testing facilities upgrading (lot release of imported vaccines including laboratory testing, QC testing of Biosimilars, determination of impurities and contaminants)

Way Forward 78

3. Alignment with other government agencies – NCPAM

– PRC- BOP

– PDEA

– BOC

– BHFS

– NCDPC

– NEC/EPI

4. Partnerships with professional associations – Philippine Pharmaceutical Association

– Philippine Medical association

Way Forward 79

Conclusion

The CDRR still commits to

1. Reduce the backlog to 25% or 10% hoping for a more robust IT infrastructure and provision of more desktops or laptops

2. Given the right resources, the CDRR is committed to speed up the processing of applications

3. Continue working on the policies to provide clarity to our work process

80

THANK YOU!

KAPIHAN AT TALAKAYAN - ww2.fda.gov.ph Kapihan - 04... · •Revision to AO 56 s. 1989, licensing of...

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