ASEAN Harmonization on Traditional Medicine and Health Supplement

Registration Requirement

N. BUNYAPRAPHATSARA

ASEAN

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• Brunei• Indonesia• Malaysia• Philippines• Singapore• Thailand

• Cambodia• Laos• Myanmar• Vietnam

ASEAN Political – Security Community(APSC)

ASEAN Economic Community (APEC)

ASEAN Socio – Cultural Community (ASCC)

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AEC

• Single market and production base• Accelerating regional integration• Facilitating movement of business

persons, skill labours and talents• Strengthening the institutional

mechanisms of ASEAN

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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

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Free Flow of Goods

• Tariff• Non tariff barrier• Custom integration• ASEAN single window• Standard and technical barriers to trade

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ASEAN Module for TMHS

• Harmonization of technical requirement• ATSC (ASEAN THMS Scientific Committee)

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TMHS Claims

• TM Claims Framework• HS Claims Framework

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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

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• 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

Key Principles (cont.)

TM Claims

• Treatment• Prevention• Relief of symptoms

of diseases

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Types of Claims

• Traditional health use claims• Traditional treatment claims• Scientifically established treatment

claims

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• 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

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

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• 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

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

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• 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

Evidence to substantiate TM Claims III

Total of 2 or more

Compulsory evidence• Scientific evidence from human studies (intervention) on

TM ingredient or productAt 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

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HS Claims

• General or Nutritional• Functional• Disease risk reduction

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• 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

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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

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• 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

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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

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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

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• 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

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Evidence to substantiate HS Claim III

Total of 2 or more of the following evidenceCompulsory evidence• Scientific evidence from human intervention study

on ingredient or productAt 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

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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

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Toxicity Data Required for

a. New ingredients/ substancesb. 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

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Data Required

• Overview of available safety information/ knowledge

• Summary of toxicity/ safety papers available

• Toxicity safety study requirement

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TMHS Ingredient/ Substances/ Products defined under a,b & c

Assessment on safety available3.1 Safety overview on available data/ knowledge3.2 Literature review of published toxicity/ safety paper available

Sufficient safetyData obtained from 3.1 & 3.2

Insufficient safety Data from 3.1 & 3.23.3 Toxicity study requirements (company owned data)

a. New Ingredient/ Substances

b. New MethodsIngredient/ substances derived from new methods of purification or extraction

c. New UsagesExisting 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.)

Sub-chronic and/ or chronic toxicity and/ or other toxicity studies are required, if applicable

Sub-chronic or chronic toxicity studies are required, if applicable

Toxicity study should be conducted in accordance to its usages on a case by case basis. 30

Restricted List of Active Substances for THMS

• Aconitum Carmichael• Bufo kusnezaffii• Berberis app

etc.

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Stability Study & Shelf-life

• Guideline for stability study• Accelerated stability data (6 months)• Real time stability study (2 years)

Study Design

• Selection of batches• Specification/ testing parameter• Testing frequency• Storage condition• Container closure system

Products Containing ingredients without known marker

• Gross organoleptic analysis• Macroscopic analysis• Microscopic analysis• Other scientific criteria

ASEAN Consultation Committee(ACCC)

• For standard and quality

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• 3 Working groups• 8 Product working group

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ASEAN Consultative Committee forStandards and Quality (ACCSQ)

Core Activities

• Standards and technical requirements• Technical regulations• Conformity assessment procedures

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TMHS

• GMP– Raw material– In – process control– Products

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Positive Impact

• Economic impact– Be able to compete with other regions

• Social impact– Consumers protection

Negative Impact

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

Thank You