Keynote Speech Direction & Guidance on Pharmaceutical Industry Development : ASEAN Harmonization on GMP-PIC/S Requirements

Transcription

1 Keynote Speech Direction & Guidance on Pharmaceutical Industry Development : ASEAN Harmonization on GMP-PIC/S Requirements Yuppadee JAVROONGRIT, Ph.D. Senior Expert on Pharmaceuticals Standard Food and Drug Administration (ThaiFDA) Ministry of Public Health, THAILAND GMP-PIC/S Thailand-PIC/S Accession-What s the Learning Curve The Novotel Platinum Pratunam Hotel, BKK, Thailand 19 September 2016

2 Presentation Outline PPWG- ASEAN Harmonization ASEAN PPWG-MRA on GMP Inspection PPWG vs. ICH vs. PIC/S Direction & Guidance

3 Presentation Outline PPWG- ASEAN Harmonization ASEAN PPWG-MRA on GMP Inspection PPWG vs. ICH vs. PIC/S Direction & Guidance

4 ASEAN = Association of Southeast Asian Nations Established = 8 Aug Size ~ 4.5 mil.km 2 ASEAN population ~ 600 million

5 Three Pillars of ASEAN Community

6 ASEAN Economic Community

7 The Goal on Economic ASEAN Leader Summit ASEAN Economic Community (AEC) by the year ASEAN will be Single Market and Single Production Base Free flow of Goods Free flow of Services Free flow of Investment Free flow of Capitals Free flow of Skilled Labour

8 Leader s Mandate to accelerate ASEAN Harmonization towards AEC for 12 Priority Products Healthcare Agro-based products Air traveling Automotive e-asean sectors Electronic & Electric Equip. Fisheries Logistics Textiles and apparels Tourism Rubber-based products Wood-based product 8

9 the AEC Aim create stable, prosperous, and highly competitive ASEAN Economic region Shall :- establish ASEAN as Single Market and Production base institute new mechanisms and measures to strengthen the implementation of its existing economic initiatives AFTA, AFAS, and AIA accelerate regional integration in the Priority sector improve the Dispute Settlement Mechanism AFTA = ASEAN Free Trade Area AFAS = ASEAN Framework Agreement on Services AIA = ASEAN Investment Area

10 1. Single Market & Production Base 2. High Competitive Economic Region free flow of Goods free flow of Services free flow of Investment free flow of Skilled Labour free flow of Capitals AEC 2015 e-asean tax & tariff competitiveness IPR Consumer protection Infrastructure Development 3. Equitable Economic Development bridging Old & New Members SMEs 4. Fully integrated into Global Economy FTAs with Non-ASEAN enhance Economic Cooperation Ref. Dept. of Trade Negotiation, Thailand 10

11 AEC the Measures/Mandates ASEAN Charter AEC Blueprint AEC Scorecard ASEAN Good Regulatory Practice (GRP) ASEAN Trade Facilitation Work Programme ASEAN Trade in Goods Agreement (ATIGA) Establishment.. 1. Legal unit 2. ACB (ASEAN Compliance Body) 3. ACT (ASEAN Consultation to Solve Trade and Investment Issues)

12 ASEAN International Cooperation

13 5 FTAs of ASEAN & Partners AJCEP * Goods /Services / Investment AANZFTA * Goods / Services/ Investment ACFTA Goods/ Services / Investment AJCEP = ASEAN-Japan Comprehensive Economic Partnership Agreement AIFTA * Goods * Services/ Investment - negotiating AKFTA Goods / Services / Investment

14 The ASEAN- Cooperation ASEAN Summit Economic Cooperation (AEC) AEM SEOM ACCSQ WG1 - Mutual Recognition Arrangements (MRAs) & Standards WG2 - Accreditation and Conformity Assessment WG3 - Scientific/Industrial Metrology ACC - ASEAN Committee on Cosmetic PPWG - Pharmaceuticals PWG Pf PWG - Prepared Foodstuff PWG TMHS PWG - Traditional Medicine & Health Supplement PWG Medical Devices&Equipment PWG EE PWG- Electrical and Electronic PWG A PWG - Automotives PWG RB PWG - Rubber-based PWG. - Political & Security Cooperation (APSC) - Socio-cultural Cooperation (ASCC) AHMM ASCC Council ASOD SOMHD AWGPD ASEAN Working Gr. on Pharmaceuticals Dev. ASEAN Sectoral Working on Traditional Medicine Initiatives on Traditional Medicine ThaiFDA proactive role in ASEAN AEC continue Proactive on POST 2015 Activities!

15 PPWG ACCSQ/PPWG 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 15

16 Pharmaceuticals PWG (PPWG) Principle to promote Registration, Trade, & Co-operation to eliminate TBT Scope to harmonize ASEAN Pharmaceutical Registration Output ASEAN Harmonized Product (ACTR, ACTD, guidelines) Mutual Recognition Agreement (MRA)

17 The PPWG Lead country & Assignment (1) Chair country : Malaysia Co-Chair country : Thailand ACTR : Quality Indonesia Safety Philippines Efficacy Thailand ACTR-Guidelines : Analytical Validation Thailand BA/BE Studies Malaysia Process Validation Singapore Stability Study Indonesia

18 The PPWG Lead country & Assignment (2) ACTD : Overall ACTD & ACTD Organization Thailand Administrative & Glossary Malaysia Quality Indonesia Non-Clinical Philippines Clinical /Efficacy Thailand IWG : Singapore (Chair) Indonesia (Co-Chair) MRA-GMP : Singapore / Malaysia (Co-Chairs) MRA-BA/BE: Indonesia / Malaysia (Co-Chairs) Post-marketing Alert System (PMAS): Singapore / Malaysia Biologics coop. Indonesia/Singapore

19 The PPWG Recognition & Agreement to facilitate AFTA & AEC to eliminate Technical Barrier to Trade (TBT) to align to International Standards without compromising on Q, S, E of Pharmaceuticals Product License the Decision of individual Member Country

20 Agreement of the ASEAN PPWG & ASEAN GMP MRA!

21 Working Scheme of the PPWG Comparative study on Registration Requirement & Regulation Identification the Key Area on Requirements for Harmonization the Works - Lead Countries /Members - Tech. discussion gr. -Dialogue w/ Association -IWG -MRA Task forces /JSC -HOD -Plenary PWG Endorsement (ACCSQ / SEOM / AEM / ) the Meetings Agreement (ASEAN Harmonized Product, MRAs) Implementation Capacity Building/Strengthening Agreement * ACTR, ACTD, Technical guidelines * Full implementation timeline * ASEAN Sectoral MRA on GMP Inspection * PMAS * Variation guideline Current Activities * Implementing ASEAN Har.products - for new application - for existing Drug license (by 2012) * GMP-MRA JSC Listed GMP Inspectorate Unit * MRA-BA/BE Study Report * Updating Tech.gls. * New areas of integration: Biological, Biotech., Biosimilar product * Facilitating the AEC * Coop. international forum: WHO, ICH, etc. * Training activities

22 Presentation Outline PPWG- ASEAN Harmonization ASEAN PPWG-MRA on GMP Inspection PPWG vs. ICH vs. PIC/S Direction & Guidance

23 ASEAN PPWG MRA on GMP Inspection (1) Formation of ASEAN MRA Taskforce(TF) on GMP Inspection * by PPWG/ACCSQ in 2005 * Chair by Singapore / Co-Chair by Malaysia ASEAN Sectoral MRA on GMP Inspection * signed by AEM on 10 Apr.2009, Pattaya, Thailand * PIC/S Framework, as Basis for the MRA * scope on GMP Report of Finished Dosage Forms for Registration (excludes APIs, Biologics, CT products, Herbal Med.) * Obligation: - AMS obliged to operate a PIC/S-equivalent GMP Inspection Framework - AMS obliged to accept GMP Certificates/Reports issued by Listed Inspection Services (i.e. AMS that meets PIC/S requirement) Ref. Mr.Sia Chong Hock/Chair of JSC GMP MRA

24 ASEAN PPWG MRA on GMP Inspection (2) Formation of JSC * by PPWG/ACCSQ in 2012, in which the TF was dissolved. * to implement the signed the GMP MRA * to establish an ASEAN Register of Listed Inspection Services (LIS) ASEAN Sectoral MRA on GMP Inspection the LIS * HSA, Singapore (since 1 Jan 2000) * NPCB, Malaysia (since 1 Jan 2000) * BPOM, Indonesia (since 1 Jul 2002) * FDA, Thailand (since 13 Mar 2015) - officially applied in Jun.2012 (via ASEAN PoE route) - ASEAN PoE assessment of ThaiFDA, week of 8-12 Sep.2014) - the 22 nd PPWG Meeting, agreed and endorsed ThaiFDA as listed Inspection Service under the ASEAN Sectoral MRA on GMP Inspection for Manufacturers of Medicinal Products, as submitted by the JSC GMP MRA. Ref. Mr.Sia Chong Hock/Chair of JSC GMP MRA

25 ASEAN PPWG MRA on GMP Inspection (3) Benefits of ASEAN MRA on GMP Inspection & LIS * avoiding duplication of GMP Audits within ASEAN * saving time, resources & costs for Regulators& Industry * facilitating Trade in Medicinal Products across ASEAN * quicker access of Medicinal Products by ASEAN Patients * harmonizing ASEAN Inspection System to that of PIC/S * increase Attractiveness of ASEAN to investors of larger economies Ref. Mr.Sia Chong Hock/Chair of JSC GMP MRA

26 ASEAN PPWG MRA on GMP Inspection (4) Looking Beyond AEC 2015 * increase # of ASEAN LIS - PhFDA: 8 Mar.2015 officially submitted Application 1 Dec.2015 an ASEAN PoE was formed to carry out a preliminary assessment (ThaiFDA-Mr.Pinpong INTARAPANICH) Currently ASEAN PoE is conducting further assessment. And when PhFDA is ready, the on-site assessment will be conducted. Final Assessment Report will then be presented to ASEAN MRA JSC & PPWG for approval/endorsement. - Viet Nam is interested to apply for ASEAN LIS * train ASEAN Inspector * Expand Scope of ASEAN MRA on GMP Inspection (include APIs, Biologics, etc) * Connect ASEAN with Asia & Rest of the World (Korea, Japan, China, USA, EU, ISPE, PIC/S, WHO, etc) Ref. Mr.Sia Chong Hock/Chair of JSC GMP MRA

27 Presentation Outline PPWG- ASEAN Harmonization ASEAN PPWG-MRA on GMP Inspection PPWG vs. ICH vs. PIC/S Direction & Guidance

28 Global/Regional Regulatory Harmonization/Convergence/Coop. Scope - Technical, Guideline, Procedure Coverage - NCEs, Generic, Herbal med.,.. Topic - GMP Inspection, Drug Evaluation, PQP, etc WHO (>190 countries) ICH (EU+Japan+USA) PIC/S (DRAs & ICH & WHO-PQ) RHSC (APEC-LSIF) PWGs /AWGPD (ASEAN) PANDRH (Pan American) SADC (South Africa) GCC (Middle East) BIMST-EC (South Asia)

29 ICH & ASEAN-PPWG& PIC/S & WHO EU+Japan+USA ICH ICH ASEAN PPWG Since 1990 Reform in Jan.2016 Since 1999 NMEs NMEs & Generic Top 3 Countries/Region of the World R&D 10 ASEAN Countries Initiator : - Harmonization Model - Q/S/E/M Technical Guidelines Utilizer ICH Model & Tech. gls. ASEAN PPWG ASEAN PPWG invited Observer to GCG/ICH PIC/S & WHO Expert in ICH-EWG, i.e. Q7 etc.

30 ASEAN PPWG vs. ICH Technical gls. Current valid gls.(step 5, as of 10 Mar.15) 108 gls. ICH tech. gls. Total New PPWG-Adoption Efficacy (E) Safety (S) Quality (Q) Multidisciplinary Adoption/Not-adoption by PPWG (as adopted gls., accept as reference gls., not-adopted) 22 nd PPWG Meeting noted recommendation to consider make use of Quality and Multidisciplinary Guidelines 30

31 Presentation Outline PPWG- ASEAN Harmonization ASEAN PPWG-MRA on GMP PPWG vs. ICH vs. PIC/S Direction & Guidance

32 ASEAN Leaders MANDATES Tasks to Members AFTA AEC Int l Std. Facilitate Trade Harmonization Requirement Std. & Conformance Common Requirements MRA

33 Overall Process in Thailand Regional Agreement-Implementation - ASEAN Following & Strengthening!

34 PPWG- Post 2015 Activities Principle 1. Sectoral MRA on GMP Inspection for Manufacturers of Medicinal Products a. increase # of LIS via either PIC/S membership or PoE route b. Capacity Building c. Expand scope of MRA to include APIs and Biologics, when 5 or more NDRAs have been included in LIS d. Development of new guidelines in the area of Biologics including Cell and Gene Therapy 2. ACTD/ACTR a. Include requirements for biologics in ACTR/ACTD b. updated & expanded version of ACTD/ACTR, i.e vaccine c. Development of technical guideline related to vaccine d. Joint Assessment Scheme & Regulatory Framework 3. ASEAN Sectoral MRA on BE Study Report a. Signing MRA on BE Study Report b. Establishing the requirements, rules and procedures for the JSC... c. Evaluate the structure of ACCSQ-PPWG to accommodate the JSC of BE Study Report d. Establishing the requirements, rules and procedures for Panel of Experts (PoE) e. Awareness Raising and Readiness of BE Centre f. PoE Establishment g. Capacity building for inspector (NDRA) of BE and BE centres, including Joint Inspection with AMS for overseas inspection h. Implementation of MRA on BE Study Report 4. Expand scope of PMAS - to include Adverse Events Following Immunisation (AEFI) since ACTR/ACTD now includes Biologics 5. Participation of PPWG rep. in the international org., such as ICH, PIC/S, European Pharmacopeia Commission 6. Cooperation with WHO/ Dialogue Partners/International Organization (i.e. ICH, PIC/S, MFDS,) 7. Collaboration with Private Sectors, i.e APC and APRIA and other relevant stakeholders 8. Possible establishment of an ASEAN vaccine manufacturing programme

35 ICH Quality Guidelines Q1A-Q1F Stability Q2 Analytical Validation Q3A-Q3D Impurities Q4A-Q4B Pharmacopoeias Q5A-Q5E Quality of Biotechnological Products Q6A-Q6B Specification Q7 Good Manufacturing Practice Q7-Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients- Q7 Q&AsQuestions and Answers: -Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q8 Pharmaceutical Development Q8(R2)-Pharmaceutical Development Q8/9/10 Q&AsR4-Q8/Q9/Q10 Implementation Q9 Quality Risk Management Q9-Quality Risk Management Q8/9/10 Q&AsR4-Q8/Q9/Q10 - Implementation Q10 Pharmaceutical Quality System Q10-Pharmaceutical Quality System Q8/9/10- Q&AsR4Q8/Q9/Q10 - Implementation Q11 Development and Manufacture of Drug Substance Q11-Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11 Q&AsQuestions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances Q12 Lifecycle Management Q12-Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

36 Perspective- Guidance Understand ASEAN Sectoral MRA for GMP Inspection Get Ready for Expansion on Scope of the MRA Study PIC/S Requirement & Guidances Study ICH Quality Guidelines- Q7-Q12 Work/Cooperation, closely, with ThaiFDA

37 Stronger Together!!!