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 Association of Southeast Asian Nations

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.

Thank You

•  Back-up Slides follow

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.

ASEAN Association of Southeast Asian Nations

•  Brunei •  Cambodia •  Indonesia •  Laos •  Malaysia •  Myanmar •  Philippines •  Singapore •  Thailand •  Vietnam