1. ASEAN Harmonisation Update: Progress Towards Finalisation & Challenges Daniel Quek Chairman, ASEAN Alliance of Health Supplement Associations Anaheim 11 March 2011

3. ASEAN KEY STATISTICS HEALTH SUPPLEMENTS STATISTICS
US$4.8 billion market size (2010 est.)
CAGR of 10% for the past 7 years
Employment for >10 million people & > 30 million dependants

4. ASEAN Harmonisation TMHS Update
Overview
ASEAN TMHS Harmonisation
AAHSA Involvement
Role of AAHSA
III Critical Period
2011 – 2015
IV Challenges Ahead
Maintain Focus in Crucial 2 Years Ahead

5. I. Overview of ASEAN TMHS Harmonisation
Objective
To facilitate trade in TMHS products and pave way for the eventual ASEAN economic integration by 2015
Projected Timelines
2011 – finalization of the harmonised TMHS regulatory framework and guidelines
2012 – signing of the agreement for the transposition of the harmonised framework into national legislation by 2014
2014 – last date for the transposition of harmonised framework into the national legislation of Member States
2015 – ASEAN Economic Community enters into force

6. Overview of ASEAN TMHS Harmonisation Tasks
Regulatory
Framework
Guidelines
Guidelines
QUAL I TY
Negative List Active Ingredients
SAFETY
GMP Requirements
Restricted List Active Ingredients
ASEAN
TMHS
Regulatory
Framework
Stability Data Requirements
Restricted List Additives /Excipients
LABEL
Labeling Requirements
Maximum Levels of Vits & Mins
Product Claim Requirements
Limits of Microbial Contamination
Total 17 tasks.
PLACEMENT
Safety Data Requirements
Limits of Contaminants / Heavy Metals
Efficacy Data Requirements
Limits of Pesticides
Product Dossier Requirements
Minimizing TSE Risks

7. AAHSA Involvement in ASEAN TMHS Harmonisation
Proactive Roles
AAHSA is a TMHS PWG member
AAHSA single voice for HS industry views
ASEAN TMHS PWG Scientific Committee & Secretariat
Lobbying Efforts with National HS Regulators
AAHSA expertise in support of Tasks
4) Technical support to ASEAN TMHS Regulation development => PWG and ATSC
5) AAHSA Scientific Committee (ASC) incl. secretariat

8. AAHSA Involvement as Part of ASC
Guidelines
Guidelines
Part of ASC
Secretariat:
Supporting
ATSC & PWG
Meetings
Organize
ASC
Meeting and
Coordination
w /international
experts.
QUAL I TY
Negative List Active Ingredients
SAFETY
GMP Requirements
Restricted List Active Ingredients
Stability Data Requirements
Restricted List Additives/ Excipients
LABEL
Labeling Requirements
Maximum Levels of Vits & Mins
Product Claim Requirements
Limits of Microbial Contamination
PLACEMENT
Safety Data Requirements
Limits of Heavy Metals
Efficacy Data Requirements
Limit of Pesticides
Product Dossier Requirements
Minimizing TSE Risks

9. AAHSA Involvements in the ASEAN TMHS Tasks
Timeline
QUAL I TY
GMP Requirements
Possible to complete by end of 2011
May take longer time to complete as there are ongoing discussions on batch selection, study conditions, and data submission.
Stability Data Requirements
LABEL
May take longer time to complete as Authorities want to see a List of well-established HS claims based on individual ingredients .
Product Claim Requirements
PLACEMENT
Safety Data Requirements
Will take longer time due to there are major issues that need to be discussed..
Efficacy Data Requirements
Will take longer time as this is very much linked to claim requirements. Decision needs to be made on claim requirements before this task could be discussed.

10. KEY TASKS WHERE AAHSA CO-LEADS
ATSC:
- Claim Requirements: Philippines/AAHSA
- Maximum Level of Vits/Mins: Thailand/AAHSA
- Negative List of Ingredients: Indonesia/AAHSA
PWG :
- Stability and Shelf-Life Guidelines: Indonesia/AAHSA
- Safety and Efficacy Data Requirements : Indonesia/Philippines/AAHSA

11. Rough Timelines for
Jan- Dec Collect feedback from relevant parties & communicate with health authorities; Scientific & Lobbying efforts to promote industry views
Jan2012 – Dec Preparation to comply with new regulations in SEA countries incl. Training; Support health authorities for the training for implementation via AAHSA / National HS Association
Jan – Dec Product re-registration or registration according to the new requirements.
Jan ASEAN Economic Community enters into force ( Grace period for some products and gradual implementation for less developed countries)

12. Key Issues / Challenges
Actively engage regulators in TMHS working group & present industry views
Provide ASEAN HS Industry single consolidated viewpoint
Common goal for industry growth & consumer safety
Areas for Industry action :
Industry coordination both Local & ASEAN
Clarity of position across industry
Regulatory, technical, scientific resource to provide input into the harmonisation process
Support for TMHS PWG and related meetings
IADSA ongoing support for TMHS Harmonisation

13. 2011 Key Considerations
Smaller and smaller group in AAHSA with bigger and bigger workload.
Going to require more intense activity as we go into this year.  
Thanks for IADSA's support esp. for ATSC extra meetings ; but this is just the start of what will be a very intensive two years of work.
Need to recognise that subsequent progress will be dependent on the political will of the Member States - level of determination to harmonise.

14. Thank You for Your Attention
End of Presentation
Thank You for Your Attention