TM: Traditional Medicine HS: Health Supplements

1. ASEAN Harmonization on Traditional
Medicine and Health Supplement
Registration Requirement
N. BUNYAPRAPHATSARA

2. ASEAN
• Brunei
• Indonesia • Cambodia
• Malaysia • Laos
• Philippines • Myanmar
• Singapore • Vietnam
• Thailand
2

3. ASEAN Political – Security Community
(APSC)
ASEAN Economic Community (APEC)
ASEAN Socio – Cultural Community (ASCC)
3

4. AEC
• Single market and production base
• Accelerating regional integration
• Facilitating movement of business
persons, skill labours and talents
• Strengthening the institutional
mechanisms of ASEAN
4

5. Single Market and Production Base
• Free flow of goods
• Free flow of services
• Free flow of investment
• Free flow of capital
• Free flow of skilled labours
• Priority integration sectors
• Food, agriculture and forestry
5

6. Free Flow of Goods
• Tariff
• Non tariff barrier
• Custom integration
• ASEAN single window
• Standard and technical barriers to trade
6

7. ASEAN Module for TMHS
• Harmonization of technical requirement
• ATSC (ASEAN THMS Scientific Committee)
7

8. TMHS Claims
• TM Claims Framework
• HS Claims Framework
8

9. Key Principles
• Be consistent with the ASEAN working definition of TM
and HS
• 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 traditional usage and/ or scientific
evidence which is proportionate to the type of claims
• Meet the dosing recommendations stated in the
evidence or references for the claimed intended effects,
if applicable
9

10. Key Principles (cont.)
• 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 health maintenance and treatment of disease in
according to traditional principles and practice, where the
product is a TM

11. TM Claims
• Treatment
• Prevention of diseases
• Relief of symptoms
11

12. Types of Claims
• Traditional health use claims
• Traditional treatment claims
• Scientifically established treatment
claims
12

13. • Type of TM claims I : Traditional Health Use
• Level of evidence: Evidence from documented traditional
use and knowledge
• Criteria for well-documented accepted TM
claims
– Claims for general health maintenance or enhancement are
documented in authoritative TM reference
– In accordance to TM principles and practice
– Adhere to the key principles ASEAN TM/HS claims

14. Evidence to substantiate TM Claims I
Total of 1 or more
• Document traditional or history of use
• Classical TM texts
• Authoritative reference texts
• Recommendations or approval on claims usage
from authority or reputable organizations
recognized by ASEAN THMS
14

15. • Type of TM claims II : Traditional Treatment
• Level of evidence: Evidence from documented traditional
treatment
• Criteria for well-documented accepted TM
claims
– Claims for treatment and prevention are documented in
authoritative TM references
– In accordance with TM principles and practice
– Adheres to the key principles of ASEAN TM/ HS claims

16. Evidence to substantiate TM Claims II
Total of 2 or more
• Documented traditional or history of use
• Classical TM texts
• Authoritative reference texts
• Recommendations or approval on claimed
usage from authority or reputable organization
reorganization recognized by ASEAN TMHS
16

17. • Type of TM claims III : Scientifically Established
Treatment
• Level of evidence: Scientific data and TM principles
• Criteria for well-documented accepted TM
claims
– Claims for treatment are approved by a recognized regulatory
authority based on human intervention studies
– In line with TM principles
– Adheres to the key principles

18. Evidence to substantiate TM Claims III
Total of 2 or more
Compulsory evidence
• Scientific evidence from human studies (intervention) on
TM ingredient or product
At least 1 additional evidence
• Documented traditional or history of use
• Authoritative reference texts
• Recommendations or approval on claimed usage from
authority or reputable organized by ASEAN member
states
• Authoritative TM clinical practice reference texts
• Scientific evidence from animal studies
18

19. HS Claims
• General or Nutritional
• Functional
• Disease risk reduction
19

20. • Type of HS claims I : General or Nutritional
• Level of evidence : General
• Criteria for well-documented acceptable HS
claims
– The claims is related to human in line with scientific or
traditional knowledge
– Documented in authoritative reference texts
– Recognized by reputable or international
organizations or regulatory authorities
– Claim is not referring to structure and function of body
– Adheres to the key principles of ASEAN TM/HS
claims
20

21. Evidence to substantiate HS Claim I
Total of 1 or more of the following evidence
– Authoritative reference texts
– Recommendation from reputable/ international
organizations or approval, where applicable, from
regulatory authorities
– Documented history of use
21

22. • Type of HS claims II : Functional
• Level of evidence : Medium
• Criteria for Well-documented acceptable HS
Claims
– Functional claim is in line with established knowledge
on nutrition and physiology
– Documented in authoritative reference texts
– Recognized by reputable or international
organizations or regulatory authorities
– Adheres to the key principles of ASEAN TM/HS
claims
22

23. Evidence to substantiate HS Claim II
At least 1compulsory evidence:
• Good quality scientific evidence from human
observational studies (in the event that human study
is not feasible, animal studies shall only be
acceptable together with other scientific literature
and documented traditional use)
• Authoritative reference texts
• Recommendations from reputable/ international
organization or approval, where applicable, from
recognized regulatory authorities
23

24. Evidence to substantiate HS Claim II
(cont.)
At least 1 additional evidence
• Scientific evidence from animal studies
• Documented history of use
• Evidence from published scientific review
24

25. • Type of HS claims III : Disease risk reduction
• Level of evidence : High
• Criteria for Well-documented acceptable HS
Claims
– The relationship between the HS ingredient or
product and disease risk reduction is supported by
consistent scientific evidence
– Documented in authoritative reference texts
– Recognized by reputable or international
organizations or regulatory authorities
– Adheres to key principle of ASEAN TM/HS claims
25

26. Evidence to substantiate HS Claim III
Total of 2 or more of the following evidence
Compulsory evidence
• Scientific evidence from human intervention study
on ingredient or product
At least 1 additional evidence:
• Authoritative reference texts
• Recommendations from reputable/ international
organizations or approval, when applicable, from
regulatory authorities
• Evidence from published scientific reviews or meta-
analysis 26

27. Safety of TMHS
• Toxicity data not required for
– TM with long history of safe use
– HS which has been consumed as food or food
constituents within the usage limit
27

28. Toxicity Data Required for
a. New ingredients/ substances
b. Ingredients/ substances/ derived from
new methods of purification or extraction/
manufacturing
c. Existing ingredients/ substances/ products
with new applications
d. Existing ingredients/ substances with
safety concern
28

29. Data Required
• Overview of available safety information/
knowledge
• Summary of toxicity/ safety papers
available
• Toxicity safety study requirement
29

30. TMHS Ingredient/ Substances/ Products defined
under a,b & c
Assessment on safety available
3.1 Safety overview on available data/ knowledge
3.2 Literature review of published toxicity/ safety paper available
Sufficient safety Insufficient safety Data from 3.1 & 3.2
Data obtained from 3.1 & 3.3 Toxicity study requirements (company owned data)
3.2
a. New Ingredient/ b. New Methods c. New Usages
Substances Ingredient/ substances derived Existing ingredient/ products with
from new methods of purification new usages in term of
or extraction composition, dosage form,
usages/ indication, route of
administration, special target
population e.g. pregnant women,
children, etc.)
Sub-chronic and/ or chronic Sub-chronic or chronic toxicity
toxicity and/ or other toxicity studies are required, if Toxicity study should be
studies are required, if applicable conducted in accordance to its
applicable usages on a case by case
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basis.

31. Restricted List of Active
Substances for THMS
• Aconitum Carmichael
• Bufo kusnezaffii
• Berberis app
etc.
31

32. Stability Study & Shelf-life
• Guideline for stability study
• Accelerated stability data (6 months)
• Real time stability study (2 years)

33. Study Design
• Selection of batches
• Specification/ testing parameter
• Testing frequency
• Storage condition
• Container closure system

34. Products Containing ingredients
without known marker
• Gross organoleptic analysis
• Macroscopic analysis
• Microscopic analysis
• Other scientific criteria

35. ASEAN Consultation Committee
(ACCC)
• For standard and quality
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36. ASEAN Consultative Committee for
Standards and Quality (ACCSQ)
• 3 Working groups
• 8 Product working group
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37. Core Activities
• Standards and technical requirements
• Technical regulations
• Conformity assessment procedures
37

38. TMHS
• GMP
– Raw material
– In – process control
– Products
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39. Positive Impact
• Economic impact
– Be able to compete with other regions
• Social impact
– Consumers protection

40. Negative Impact
• SMEs
– Large investment for improving
– Several studies to support the claims & safety
– Stability studies

41. Thank You