Post on 06-Mar-2018
ASEAN Health Supplements Regulatory Harmonisation Update
Daniel Quek Health Supplements Industry Association of Singapore ASEAN Alliance of Health Supplement Industry Associations @ IADSA AGM in Istanbul,Turkey 24 February 2010
ASEAN SECURITY COMMUNITY
ASEAN ECONOMIC COMMUNITY
ASEAN SOCIAL COMMUNITY
3 PILLARS Targeted for 2020
ACCSQ ASEAN Consultative Committee for Standards and Quality
Traditional
Medicines / Health
Supplements Product
Working Group AEM: 11 priority sectors accelerated to 2010 including health supplements
ASEAN industry representation on HS
regulations AEM : Accelerate to 2015
ASEAN Harmonization of TMHS
Definitions
Product Placement
Claims
Ingredients and levels
Labelling
Manufacturing Standards
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)
TMHS PWG AAHSA
IADSA
ATSC (ASEAN TMHS Scientific Committee)
ASC (AAHSA Scientific Committee) International
Scientific Panel
ASEAN TMHS Harmonisation Operational Groupings
Note : Illustrative Only
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
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
Products legal in one country can be sold in all ASEAN countries with minimal restrictions.
ASEAN HS regulatory model as a potential global standard
AAHSA Anticipates
Timeline July : 13th TMHS PWG December : 14th TMHS PWG Implementation :
• 2010 - finalization of the harmonized TMHS regulatory framework & guidelines
• 2011 - signing of agreement for ASEAN Member States to transpose the harmonized framework into national legislation by 2014
• 2014 - last date for the transposition of harmonized framework into the national legislation of Member States
• 2015 - ASEAN Economic Community enters into force
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.
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
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
TMHS PWG Tasks
PWG tasks / Leads
- 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
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
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
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.