UPDATE ON ASEAN

1
UPDATE ON ASEAN HARMONISATION
WHO Collaborating Centre For Regulatory Control
of Pharmaceuticals
National Regulatory Conference 2005 6 September
2005
Member of Pharmaceutical Inspection Cooperation
Scheme
EISAH A. RAHMAN National Pharmaceutical Control
Bureau Ministry of Health Malaysia Jalan
Universiti 46730 Petaling Jaya MALAYSIA Tel
603-79573611 Fax [phone]
MS ISO 90012000 Certified
2
PRESENTATION OUTLINE

• Introduction
• ASEAN Cooperation on Standards and Conformance
• Pharmaceutical
• Cosmetics
• Traditional Medicines and Health Supplements
• ASEAN Healthcare Integration

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INTRODUCTION

• ASEAN Free Trade Area (AFTA) collective effort to
  reduce/eliminate tariffs on intra-ASEAN trade in
  the goods sector.
• Objective of AFTA to enhance ASEANs position as
  a competitive production base for regional and
  global markets.
• Initiatives to promote and facilitate trade
  through harmonization.
• Access into larger market of 530 million
  population.

4
Collaboration with WHO and Dialogue Partners
ASEAN Working Group on Technical Cooperation in
Pharmaceuticals
ASEAN Consultative Committee for Standards
Quality
EC-ASEAN Economic Cooperation
Pharmaceutical Product Working Group
Cosmetic Product Working Group

Traditional Medicines Health Supplements Product
Working Group
ASEAN Cosmetic Committee
ASEAN TECHNICAL COOPERATION
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STANDARDS AND CONFORMANCE

• Meeting standards essential for business success.
• ACCSQ established in 1992 to eliminate technical
  barriers to trade.
• Focus on harmonization of standards, technical
  regulation and mutual recognition arrangements on
  conformity assessments.

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ACCSQ STRUCTURE
ASEAN CONOMIC Ministers Meeting (AEM)
ASEAN Senior Economic Official Meeting (SEOM)
ASEAN Consultative Committee for Standards and
Quality (ACCSQ)



PWG Traditional Medicines Health Supplements
PWG Cosmetics ACC
PWG Pharma
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PWG Pharmaceutical

• 10th Meeting in Singapore, August 2005
• ASEAN BA/BE Studies
• Stability Issues
• ASEAN Labeling Requirements

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IMPLEMENTATION

• ACTD Format
• Dateline 31st Dec 2008
• IWG Survey by Singapore
• Training Needs Analysis Training Syllabus for
  Regulators
• ASEAN Pharmaceutical Advisory Groups of Experts
  (APAGE)
• Industry Dialogues

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FURTHER ACTIONS

• Clarification on ACTD implementation
• Strengthening BA/BE capabilities
• Revision of FAQs on ACTD
• Bilateral arrangements with Singapore
• Feed-backs from industry regarding country
  specific requirements

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ASEAN Healthcare Integration

• ASEAN MRA Taskforce on GMP Inspection
• Post-marketing Alert (PMA) System Pilot Scheme
• Review progress of ACTD implementation
• Twinning system for capacity building

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International Cooperation

• WHO ASEAN Guidance on Reference Drug
  Information
• WHO Developing Countries Vaccine Regulatory
  Network
• ASEAN US
• ASEAN Australia
• EC-ASEAN Economic Cooperation

12
ASEAN Cosmetic Committee

• Agreement on ASEAN Harmonized Cosmetic Regulatory
  Scheme signed in 2003.
• Last meeting in June 2005, Malaysia
• Covers ASEAN MRA of Product Registration Approval
  and ASEAN Cosmetic Directive.
• ASEAN Cosmetic Directive effective on 1st Jan
  2008.

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ASEAN Harmonized Cosmetic Regulatory Scheme

• ASEAN COSMETIC MRA
• - Certified True Copy of Certificate of
  Product Registration
• - Notification Letter
• - Lack of interest

• ASEAN COSMETIC DIRECTIVE
• - No registration
• - Standard notification
• - Companies keep technical and safety
  information
• - Need proper infrastructure for GMP PMS

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Current Status - Malaysia

• ASEAN COSMETIC DIRECTIVE
• - Definition ?
• - Ingredient Listing ?
• - Labeling ?
• - Claims guidelines ?
• - Cosmetic GMP ?
• - Notification X
• - Product Information File X

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ASEAN COSMETIC DIRECTIVE

• Dateline for ASEAN Jan 2008
• Move towards Notification
• Emphasis on Post Market Surveillance
• Product Information File responsibility of the
  holder
• Safety and Efficacy Documents

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FOLLOW-UP ACTIONS

• Liberalize Cosmetic GMP
• Focus on Post Marketing Surveillance
• Review ASEAN Cosmetics Handbook
• Study other experience on Notification Procedure
• Transition period

17
PWG Traditional Medicines Health Supplements

• 3rd Meeting in Bali, July 2005
• Proposal by healthcare industry related to
  roadmap
• - Harmonize labelling requirements of TM HS
• - Formulate common definition and product
  category for HS
• - Establish a common positive list of allowable
  ingredients, max dosage and suggested claims for
  HS and provide a common list of
  prohibited/banned ingredients
• - Establish a harmonized list of RDI values for
  Vitamin Mineral Supplements
• - Establish a framework for allowable claims
  that define types of claims, level of scientific
  evidence demanded and local infrastructures to
  assist industry
• - Provide a list of ASEAN allowable and
  prohibited claims

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IMPLEMENTATION

• ACTR for TMHS dateline
• - 31st Dec 2007
• Harmonization on specific areas
• - Definitions and terminologies
• - Comparative studies on international and other
  regional technical requirements
• - Identification of specific areas
• Potential areas
• - Definitions and terminologies
• - Product placement
• - Safety/Quality requirements
• - Post-market surveillance
• - Monitoring adverse reactions/incidence
• - Advertisements
• - Efficacy/Claims requirements

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ACTR for TMHS

• GMP and Testing Method
• - Malaysia
• Product Placement
• - Singapore
• Labelling and Advertisement
• - Thailand
• Post Market Alert System
• - Indonesia

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CONCLUSION

• Potential for market expansion
• Minimize resources
• Faster access
• Mutual understanding and
• recognition
• Serious commitment

Thank You