Keynote Speech

ThaiFDA
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-Whats the Learning Curve

The Novotel Platinum Pratunam Hotel, BKK, Thailand
19 September 2016
YuppadeeJAVROONGRIT-19Sep2016
ThaiFDA
Presentation Outline
PPWG- ASEAN Harmonization
ASEAN PPWG-MRA on GMP Inspection
PPWG vs. ICH vs. PIC/S

Direction & Guidance
ThaiFDA

ThaiFDA
ASEAN = Association of Southeast Asian Nations
Established = 8 Aug. 1967

Size ~ 4.5 mil.Km2
ASEAN population ~ 600 million
ThaiFDA
Three Pillars of ASEAN Community

ThaiFDA
ASEAN Economic Community
ThaiFDA
The Goal on Economic

ASEAN Leader Summit
ASEAN Economic Community (AEC)

by the year 2015.. 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
ThaiFDA
Leaders 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
ThaiFDA
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
ThaiFDA
1. Single Market & Production Base
2. High Competitive Economic Region
free flow of Goods
e-ASEAN
free flow of Services
tax & tariff
free flow of Investment
AEC
free flow of Skilled Labour

free flow of Capitals
3. Equitable Economic Development
2015
competitiveness
IPR
Consumer protection
Infrastructure Development
4. Fully integrated into Global Economy
bridging Old & New Members
FTAs with Non-ASEAN
SMEs
enhance Economic Cooperation
Ref. Dept. of Trade Negotiation, Thailand
10
ThaiFDA
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.
2.
3.
Legal unit
ACB (ASEAN Compliance Body)
ACT (ASEAN Consultation to Solve Trade and Investment Issues)
ThaiFDA
ASEAN
International Cooperation
ThaiFDA
5 FTAs of ASEAN & Partners
AJCEP
* Goods /Services /
Investment
AJCEP = ASEAN-Japan
Comprehensive Economic
Partnership Agreement
AANZFTA
* Goods / Services/
Goods/ Services / Investment
Investment
AIFTA
* Goods
* Services/ Investment
- negotiating
ACFTA
AKFTA
Goods / Services /
Investment
ThaiFDA
The ASEAN- Cooperation

ASEAN Summit
Economic Cooperation (AEC)

AEM
SEOM
ACCSQ
- Political & Security Cooperation (APSC)

- Socio-cultural Cooperation (ASCC)
WG1 - Mutual Recognition Arrangements (MRAs) & Standards

WG2 - Accreditation and Conformity Assessment
WG3 - Scientific/Industrial Metrology
ACC - ASEAN Committee on Cosmetic
AHMM
ASCC Council
ASOD
SOMHD
AWGPD ASEAN Working Gr. on Pharmaceuticals Dev.
ASEAN Sectoral Working on Traditional Medicine
Initiatives on Traditional Medicine
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
.
ThaiFDA proactive role in ASEAN
AEC continue Proactive on POST 2015 Activities !

ThaiFDA
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
ThaiFDA
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
(MRA)
Recognition Agreement
ThaiFDA
The PPWG Lead country & Assignment (1)

Chair country :
Malaysia
Co-Chair country :
ACTR :
Thailand
Quality Indonesia
Safety Philippines
Efficacy Thailand
ACTR-Guidelines :
Analytical Validation Thailand
BA/BE Studies Malaysia

Process Validation Singapore
Stability Study Indonesia
ThaiFDA
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
ThaiFDA
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
ThaiFDA
Agreement of the ASEAN PPWG
& ASEAN GMP MRA !

ThaiFDA
Working Scheme of the PPWG

Comparative study
on Registration Requirement & Regulation
Identification the Key Area on

Requirements
Agreement
* ACTR, ACTD, Technical guidelines
* Full implementation timeline
* ASEAN Sectoral MRA on GMP Inspection
* PMAS
* Variation guideline
for Harmonization
the Works -Lead Countries/Members

- Tech. discussion gr.
-Dialogue w/ Association
-IWG
-MRA Task forces /JSC
-HOD
-Plenary PWG
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
the Meetings
Endorsement
(ACCSQ / SEOM / AEM /)
Agreement
(ASEAN Harmonized
Product, MRAs)
Implementation
Capacity Building/Strengthening
* Updating Tech.gls.
* New areas of integration: Biological ,
Biotech., Biosimilar product
* Facilitating the AEC
* Coop. international forum: WHO, ICH, etc.
* Training activities
ThaiFDA

ThaiFDA
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

ThaiFDA

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 22nd 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.

ThaiFDA

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
ThaiFDA

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)
ThaiFDA

ThaiFDA
Global/Regional
Regulatory Harmonization/Convergence/Coop.
Scope - Technical, Guideline, Procedure
Coverage - NCEs, Generic, Herbal med.,..
Topic - GMP Inspection, Drug
Evaluation, PQP, etc
PIC/S
ICH
(DRAs & ICH & WHO-PQ)
(EU+Japan+USA)
RHSC
(APEC-LSIF)
WHO
(>190 countries)
PWGs /AWGPD
(ASEAN)
PANDRH
(Pan American)
GCC
SADC
(South Africa)
(Middle East)
BIMST-EC
(South Asia)
ThaiFDA
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 :
Utilizer ICH Model & Tech. gls.
- Harmonization Model
- Q/S/E/M Technical Guidelines
ASEAN PPWG
ASEAN PPWG invited Observer to GCG/ICH
PIC/S & WHO Expert in ICH-EWG, i.e. Q7 etc.
ThaiFDA
ASEAN PPWG vs. ICH Technical gls.

Current valid gls.(step 5, as of 10 Mar.15) 108 gls.
ICH tech. gls.
Total
New
Efficacy (E)
31
13
10
Safety (S)
18
11
Quality (Q)
50
Multidisciplinary
PPWG-Adoption
Adoption/Not-adoption by PPWG (as adopted gls., accept as reference gls., not-adopted)
22nd PPWG Meeting noted recommendation to consider
make use of Quality and Multidisciplinary Guidelines

30
ThaiFDA
ASEAN PPWG-MRA on GMP

ThaiFDA
ASEAN Leaders MANDATES

Tasks to Members
AFTA
AEC
Intl Std.
Facilitate Trade
Harmonization Requirement
Std. & Conformance
Common Requirements
MRA
ThaiFDA
Overall Process in Thailand

Regional Agreement-Implementation - ASEAN
Following & Strengthening !

ThaiFDA
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.
b.
c.
d.
Include requirements for biologics in ACTR/ACTD

updated & expanded version of ACTD/ACTR, i.e vaccine
Development of technical guideline related to vaccine
Joint Assessment Scheme & Regulatory Framework
3. ASEAN Sectoral MRA on BE Study Report

a.
b.
c.
d.
e.
f.
g.
Signing MRA on BE Study Report

Establishing the requirements, rules and procedures for the JSC ...
Evaluate the structure of ACCSQ-PPWG to accommodate the JSC of BE Study Report
Establishing the requirements, rules and procedures for Panel of Experts (PoE)
Awareness Raising and Readiness of BE Centre
PoE Establishment
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
ThaiFDA
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
ThaiFDA
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
ThaiFDA
Stronger Together!!!

Keynote Speech

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ThaiFDA

Yuppadee JAVROONGRIT, Ph.D.

GMP-PIC/S Thailand-PIC/S Accession-Whats the Learning Curve

PPWG vs. ICH vs. PIC/S

PPWG vs. ICH vs. PIC/S

ASEAN = Association of Southeast Asian Nations

Established = 8 Aug. 1967

Three Pillars of ASEAN Community

ASEAN Economic Community

The Goal on Economic

ASEAN Economic Community (AEC)

Free flow of Goods

for 12 Priority Products

AFTA = ASEAN Free Trade Area

1. Single Market & Production Base

2. High Competitive Economic Region

free flow of Goods

free flow of Services

tax & tariff

free flow of Investment

free flow of Skilled Labour

3. Equitable Economic Development

4. Fully integrated into Global Economy

bridging Old & New Members

FTAs with Non-ASEAN

enhance Economic Cooperation

Ref. Dept. of Trade Negotiation, Thailand

AEC the Measures/Mandates

5 FTAs of ASEAN & Partners

Goods/ Services / Investment

The ASEAN- Cooperation

Economic Cooperation (AEC)

- Political & Security Cooperation (APSC)

WG1 - Mutual Recognition Arrangements (MRAs) & Standards

ACC - ASEAN Committee on Cosmetic

PPWG - Pharmaceuticals PWG

ThaiFDA proactive role in ASEAN

AEC continue Proactive on POST 2015 Activities !

compromising on drug quality, efficacy, and safety

Pharmaceuticals PWG (PPWG)

Scope to harmonize ASEAN Pharmaceutical Registration

The PPWG Lead country & Assignment (1)

Analytical Validation Thailand

BA/BE Studies Malaysia

The PPWG Lead country & Assignment (2)

Administrative & Glossary Malaysia

Clinical /Efficacy Thailand

MRA-GMP : Singapore / Malaysia (Co-Chairs)

MRA-BA/BE: Indonesia / Malaysia (Co-Chairs)

Biologics coop. Indonesia/Singapore

The PPWG Recognition & Agreement

to facilitate AFTA & AEC

Agreement of the ASEAN PPWG

& ASEAN GMP MRA !

Working Scheme of the PPWG

Identification the Key Area on

the Works -Lead Countries/Members

PPWG vs. ICH vs. PIC/S

ASEAN PPWG MRA on GMP Inspection (1)

ASEAN Sectoral MRA on GMP Inspection

Ref. Mr.Sia Chong Hock/Chair of JSC GMP MRA

ASEAN PPWG MRA on GMP Inspection (2)

ASEAN Sectoral MRA on GMP Inspection the LIS

Ref. Mr.Sia Chong Hock/Chair of JSC GMP MRA