ASEAN Health Supplements Regulatory Harmonisation Update

Transcription

1 ASEAN Health Supplements Regulatory Harmonisation Update Daniel Quek Health Supplements Industry Association of Singapore ASEAN Alliance of Health Supplement Industry IADSA AGM in Istanbul,Turkey 24 February 2010

2 ASEAN Association of Southeast Asian Nations

3 3 PILLARS Targeted for 2020 ASEAN SECURITY COMMUNITY ASEAN SOCIAL COMMUNITY ASEAN ECONOMIC COMMUNITY ACCSQ ASEAN Consultative Committee for Standards and Quality AEM : Accelerate to 2015 ASEAN industry representation on HS regulations AEM: 11 priority sectors accelerated to 2010 including health supplements Traditional Medicines / Health Supplements Product Working Group

4 ASEAN Harmonization of TMHS Definitions Labelling Ingredients and levels Claims Product Placement Manufacturing Standards

5 ASEAN Alliance of HS Associations 1) Health Foods and Dietary Supplements Association Philippines (HADSAP) 2) Association of Indonesian Health Supplement Companies (APSKI) 3) Malaysian Dietary Supplement Association (MADSA) 4) Health Supplements Industry Association of Singapore (HSIAS) 5) Health Food and Supplements Association Thailand (HFSA) 6) Vietnamese Materia Medica Society (VIMAMES) 7) Health Supplements Association of Brunei (BRUHSA) 8) Vietnam Association of Dietary Supplements (VADS)

6 ASEAN TMHS Harmonisation Operational Groupings TMHS PWG AAHSA IADSA ATSC (ASEAN TMHS Scientific Committee) ASC (AAHSA Scientific Committee) International Scientific Panel Note : Illustrative Only

7 Key Directions Maximum levels : EHPM/ERNA model is preferred one at present Claims: Developing a new model for substantiation Not following EU on claims too bureaucratic and unworkable for SMEs while consumer protection is paramount, there is no point harmonising if it is detrimental to HS companies Drive to promote HS business in a competitive world environment National Industry Associations Proactive Regulatory Affairs Management

8 AAHSA focus Maximise range of ingredients and levels of ingredients. Facilitate speedy and efficient product placement GMPs: Appropriate for small, medium as well as multinational corporations. Ability to communicate messages about products to consumers ie claims Realistic Implementation schedule Ensure equal application of the rules to ensure that there are no unnecessary restrictions

9 AAHSA Anticipates Products legal in one country can be sold in all ASEAN countries with minimal restrictions. ASEAN HS regulatory model as a potential global standard

10 Timeline July : 13th TMHS PWG December : 14th TMHS PWG Implementation : finalization of the harmonized TMHS regulatory framework & guidelines signing of agreement for ASEAN Member States to transpose the harmonized framework into national legislation by last date for the transposition of harmonized framework into the national legislation of Member States ASEAN Economic Community enters into force

11 Ensuring Further Progress 1) Continued IADSA support for AAHSA & ASEAN harmonisation for 2010 and beyond International Experts International Perspectives in HS regulation Strategic and scientific guidance/support for ASEAN TMHS Framework, ATSC and PWG tasks 2) Counter apprehension of SMEs losing out 3) Tap strengths & resources of IADSA in ASEAN.

12 Thank You

13 Back-up Slides follow

14 Key Principles of ASEAN Claims Be consistent with the ASEAN definition of HS and TM Enable consumers to make an informed choice regarding products Not be misleading or false Support the safe, beneficial and appropriate use of the products Maintain the level of scientific evidence which is proportionate to the type of claims Be for health maintenance and promotion purpose, where the product is a HS Not be medicinal or therapeutic in nature, such as implied for treatment, cure or prevention of diseases, where the product is a HS Be for treatment of disease and health maintenance in according to traditional principles and practice, where the product is a TM The claims framework and process shall be practical and clear and viable for implementation. 3 Types of HS claims Nutritional or General Claims Functional Claims Disease Risk Reduction Claims

15 ASEAN MAXIMUM LEVELS OF VITAMINS & MINERALS IN HEALTH SUPPLEMENTS Two Major Components: a) Risk Assessment based on WHO Model b) Risk Management based on ERNA Model

16 PWG tasks / Leads TMHS PWG Tasks - ASEAN TMHS Framework - Indonesia - Good Manufacturing Practices Malaysia - Product Placement - Singapore - Minimum Labeling Requirements - Thailand - Mapping Capacity Brunei / IADSA - Post Marketing Alert System - Vietnam/Singapore

17 TMHS PWG Tasks ASEAN Common Technical Requirements(ACTR): Guidelines on Product Dossier Submission - Malaysia and Singapore Guidelines on Non-clinical Requirements - Indonesia / Philippines / AAHSA Guidelines on Clinical requirements - Indonesia / Philippines / AAHSA Guidelines for Stability Study and Shelf-life - Indonesia/AAHSA

18 Asean TMHS Scientific Committee (ATSC) Tasks Guidelines on Claim Requirements - Philippines / AAHSA Guidelines on Negative List of Ingredients - Indonesia / AAHSA Guidelines on Restricted Additives and Excipients - Thailand Guidelines on Maximum Limits of Vitamins and Minerals - Thailand / AAHSA Guidelines on Contaminants - Malaysia Guidelines for minimising the risk of TSE in TM and HS - Singapore Classification of interface products - Singapore/Indonesia/Philippines

19 Lead ASEAN Industry on HS Regulatory Harmonisation To facilitate trade in quality products for the benefit of consumers. Coordination and representation of the ASEAN health supplement industry in ASEAN harmonization process. Providing regulatory, scientific, technical, market data to the harmonization process. Building and strengthening national associations. Organizing regional events Building awareness of the ASEAN industry outside the region.

20 ASEAN Association of Southeast Asian Nations Brunei Cambodia Indonesia Laos Malaysia Myanmar Philippines Singapore Thailand Vietnam