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

Transcription

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

2 ASEAN Brunei Indonesia Malaysia Philippines Singapore Thailand Cambodia Laos Myanmar Vietnam 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 Relief of symptoms of diseases 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 metaanalysis 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 Data obtained from 3.1 & 3.2 Insufficient safety Data from 3.1 & Toxicity study requirements (company owned data). New Ingredient/ ubstances Sub-chronic and/ or chronic toxicity and/ or other toxicity studies are required, if applicable b. New Methods Ingredient/ substances derived from new methods of purification or extraction Sub-chronic or chronic toxicity studies are required, if applicable c. New Usages Existing ingredient/ products with new usages in term of composition, dosage form, usages/ indication, route of administration, special target population e.g. pregnant women, children, etc.) Toxicity study should be conducted in accordance to its usages on a case by case 30 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 35

36 ASEAN Consultative Committee for Standards and Quality (ACCSQ) 3 Working groups 8 Product working group 36

37 Core Activities Standards and technical requirements Technical regulations Conformity assessment procedures 37

38 TMHS GMP Raw material In process control Products 38

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