ASEAN Harmonization on Traditional Medicines and Health Supplements

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ASEAN Harmonization on Traditional Medicines and
Health Supplements

• ??.??????? ?????????

????????????? ????????????????????????????????? ??
?????????????????????????? ???????????????? 6
????????? 2552
2

• ????????????????????? Product Working Group on
  Traditional Medicines and Health Supplements
  (PWG TMHS)
• ???????????????????????????????????????????
  ??????????? PWG TMHS
• ???????????????????????????????
• ???????????????????????

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ASEAN Member Countries 10 Countries
1. ????? 2. ??????? 3. ??????????? 4. ??? 5.
???????? 6. ???? 7. ?????????? 8. ???????? 9.
??? 10. ????????
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???????????????? 1. ??????????????????????????????
????? ???????? ????????? ???????????
???????????? ?????????????????????????????????????
????????? 2. ?????????????????????????????
??????????????????????????????????????????????????
??
?????????
?????????????????????????
???????????????????????????
??? ??????????????????????????
?????????????????????????????????? 1. Agro-based
Products 2. Fishery 3. Healthcare
---gt Traditional Medicine and Health
Supplement
???????????????????????????????????????? ???????
???????? ASEAN Consultative Committee on
Standards and Quality (ACCSQ)
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• Pharmaceutical PWG
• Prepared Foodstuff PWG
• Automotive PWG
• Traditional Medicines and
• Health Supplements PWG
• Medical Device PWG
• Wood-Based PWG
• Rubber-Based PWG

Product Working Groups
???????????? ?.?. 2547
ACCSQ
Dialogue Partners
- Japan - New Zealand - US - EU
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?????? ????????????????? ??????????
??????????????
??????????????????????????????????????????????????
??????????????????????????????????????????????????
????????????????????????
???????????????????????
1. ??????????????????????????????????????? 2.
?????????????????????????????????????????? 3.
??????????????????????????? 4.
??????????????????????????????????? 5.
???????????????????????????????????????
????????????????????????????
???????????
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• ????????????????????? Product Working Group on
  Traditional Medicines and Health Supplements
  (PWG TMHS)
• ???????????????????????????????????????????
  ??????????? PWG TMHS
• ???????????????????????????????
• ???????????????????????

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• ??????????????????????????????????????????????????
  ????????????????????????????????????? ???????????
• ???????????????????????
• ????????????????????????????????
• ?????????????????????????????????
• ???????????????????????????????????? GMP
• ??????????????????????????????????????????????????
  ??
• ??????????????????????????????????????????????????
  ?????????????????
• ??????????????????????????????????????????

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• ????????????????????? Product Working Group on
  Traditional Medicines and Health Supplements
  (PWG TMHS)
• ???????????????????????????????????????????
  ??????????? PWG TMHS
• ???????????????????????????????
• ???????????????????????

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?????????????????????????
??????????????????????????
1. ???????????????????????????????????????????????
?????????? ASEAN 2. ??????????? ??????????
??????????????????????????????????????
???????????????????????????????????????????3.
??????????????????????????????????????????????????
??????4. ????????????????????????????????????????
? ?????????????????????? ?????????????????????????
???????????????????????
1. ??????????????????????????????????????????????
?????????????????????????????? 2.
?????????????????????????????? GMP 3.
??????????????????????????? ??????????????????????
????????? 4. ????????????????????????????????????
? 5. ?????????????????????
??????
?????????
????????????
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• ????????????????????? Product Working Group on
  Traditional Medicines and Health Supplements
  (PWG TMHS)
• ???????????????????????????????????????????
  ??????????? PWG TMHS
• ???????????????????????????????
• ???????????????????????

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• 1. ?????????????????????
• 2. ???????????????????????????????????????????????
  ????
• 3. ?????????????????????????????????????
• ??????????????? ?????????? ASEAN TMHS
  Scientific Committee (ATSC)
• ?????????? ??????????? GMP ????????????????????
  ????????????????????
• 4. ?????????????????????
• 5. ????????????????????????????????
  ????????????????????????????
• (Post Marketing Alert System PMAS)
• 6. ??????????????????????????

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????????????????
1. TSE 2. Negative list of ingredient 3. Limit of
Contaminants 4. Restricted Additives and
Excipients 5. Classification of Product at
Interface 6. Maximum Levels of Vitamins and
Minerals 7. Claims Requirement
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??????????????????????????????????? ACCSQ TMHS
PWG ???????? 11 ? ????????? ????????????????? ????
????????? 27-31 ??????? 2552
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1. ?????????????????????
Health supplement means any product that
is used to supplement a diet and to maintain,
enhance and improve the healthy function of human
body and contains one or more, or a combination
of the following a. Vitamins, minerals,
amino acids, fatty acids, enzymes, probiotics
and other bioactive substances b.
Substances derived from natural sources,
including animal, mineral and botanical materials
in the forms of extracts, isolates, concentrates,
metabolite
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(cont)
1. ????????????????????? (???)
c. Synthetic sources of ingredients
mentioned in (a) and (b) may be used where the
safety of these has been proven. It is
presented in dosage forms (to be administered) in
small unit doses such as capsules, tablets,
powder, liquids and it shall not include any
sterile preparations (i.e. injectable, eyedrops)
amino acids and other bioactive substances
will be identified in the positive list
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(cont)
2. ???????????????????????????????????????????????
??????????Product Placement Requirement

• ????????????????????????????????????? ????????
• ????????? ????????????????????? (Notification)
• ????????????? ??????????????????????? (Listing)
• ????????? ???????????????????? (Listing)

• ??????????????????????????????????
• Guideline for Safety Data Requirement
• Guideline for Efficacy Data Requirement
• Guideline for Stability Study and Shelf-life of
  TM and HS
• Guideline on Product Dossier Submission

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(cont)
3. ??????????????????????? ?????????
3.1 ???????????????????????
??? ASEAN TMHS Scientific Committee (ATSC)
??????????????
3.2 ??????????????????
??????????? GMP ??????????????????????????????????
?????? ????????????????
????????????????????? GMP ??????? 2
??????????????????????????? ???????????????????
??????? 3 ?????
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(cont)
4. ?????????????????????
????????????????????

• ????? Guideline ????????????? ???????????????????
  ??
• Country specific ????????????????????????
  country specific

?????????????????????????????????
?????????????????????? 5 ???? ????????????????????
????????
??????????????????? ????????????
20
(cont)
21
(cont)
22
(cont)
23
(cont)
24
(cont)
25
(cont)
26
(cont)
27
(cont)
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(cont)
5. ????????????????????????????????
???????????????????????????? (Post Marketing
Alert System PMAS)

• ????????????????????????????????????????????
• ?????????????????????????????????????????????????
  ???????????????? Sibutamine

6. ?????????????????????????
???????????????????????????????????????????
??????????????????????????????????????
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1. TSE
???????????????????????????
????????????????????????? ????????????????????????
?? ASEAN ????????????????? ?.??.296 (?.?.)
2549 ??????????????????????????????????????
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2. Negative list
???????????????????????????? (???????)
???????????????????????????????????????
???????????????????????????? ?????????????????????
? ??????????????????????????????????????????
?????????????????????????????????????????
??????????? ????????????????????????
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3. Limit of contaminant

• Heavy metals ??????????? Pb, Cd, Hg, Cu
• ?????????????????????????????????????
• ???????????????????????????????????? ????
• Microbial ?????????????????????????????????????
  ?? BP
• E. coli, Salmonella, Staphylococcus
  aureus
• ??????????????????????????????
• Pesticide residues ??????? Task Force
  ????????????????????
  ?????????????????????? Pesticide ??????????
• ??????????????????????????????????????

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4. Restricted additives and excipients
????????????????????

• - ??????? guideline ???????????????????????????
• ??????????????????????????? ?????????????????????
  ??????????

5. Classification of products at interface
????????????????????????????? TMHS
Regulatory Framework ?????????????????????????????
???????
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????????? ?????????????????? AAHSA
6. Maximum Levels of Vitamins and Minerals

• ??????????????????? General Principle ERNA
  model
• ?????????????????????????????????????????????????
  ??????????
• ?????????????????????????????????????????????

ERNA European Responsible Nutrition Alliance
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6. Maximum Levels of Vitamins and Minerals
ML UL - MHI
ERNA Model
?????????????????????????????????????? - Upper
Limit (UL) - Mean Highest Intakes (MHI) -
Reference Labeling Value (RLV) - Uncertainty
Factor (UF)
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6. Maximum Levels of Vitamins and Minerals
PSI (UL MHI) ? RLV
????????????
Group A ????? PSI ????????????? UL Group B
PSI ? 1.5 Group C PSI ? 1.5
?????????????????????????? ??????????? 3 ?????
????????????? Group A ????????????????????? ????
??????? K, B1, B2 Group B ?????????? ????
??????? A, Copper Group C ????????? ????
Fluoride, Iron
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7. Claims Requirement
- ?????????????????????? ????????????? TM HS -
????????????????????????????????????? codex
???????? - ???????????????????????????????????????
???????????????
???????????????????? 3 ????? ?????? 1.
Nutritional or General Claims 2. Functional
Claims 3. Disease risk reduction Claims
????? 2 ??? 3 ????????????????????????????????????
?
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?. ??????
?. ???????
?.??. 293 ???????????????????
???. ????? 2522
?.??. 193 GMP
?.??. ????????????????????????????????????????????
??????????????????????????????????????????
?????????????????????????
?.??. 194, 252 ????
?.??. 182 ????????????
?.??. ?????????.??. ????????????????????????? ???
?.??.?????? ???????????????????????
?.??. 295 ??????????
?.??. ???????????? ?????????? (????)
?.??. ??????????????????????????????????? ????????
????????????????????????????????
?.??.281 ????????????????
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• 1. Raw material specification
• 2. Formulation per unit of the dietary supplement
  or percentage by weight
• 3. Production method, according to the procedures
  actually used
• 4. Product specification

FDA Notification Documentary Evidence Required
in an Application for a Dietary Supplement Label
Permit and Pathogenic Microbial Standards
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• 5. Results of analytical tests ex. Contaminants,
  Pathogenic micro-organism
• 6. Factory Certification for Imported Foods, in
  the case of imported dietary supplement
• 7. A Certificate of Free Sale
• 8. Labeling

FDA Notification Documentary Evidence Required
in an Application for a Dietary Supplement Label
Permit and Pathogenic Microbial Standards
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• At least 15 and not exceeding 100 of vitamins
  and minerals maximum limits prescribed in Thai
  RDI list
• Vitamins and minerals other than the list must be
  in accordance with that prescribed by the FDA and
  approved by the Food Committee

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Positive list for active ingredients

• The list is issued by Thai FDA Notification and
  approved by Food Committee
• Other substances not in the list and new active
  ingredients, JECFAs Safety Evaluation Criteria
  are required.

JECFA JOINT EXPERT FAO/WHO COMMITTEE ON FOOD
ADDITIVE
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The lists prescribed by FDA

• Vitamins and Minerals as active ingredients
• example --- Vitamin A, Vitamin K, Iodine,
  Fluoride
• Amino acids as active ingredients
• example --- L-phenylalanine, L-methionine

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• Require to submit
• History of safe use of ingredient/substance as
  food or
• If used in the forms modified from its original
  food forms, a report of acute toxicity studies of
  the product or
• If it no historic usage as food, a result of
  chronic toxicity test on animal must be submitted.

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  ??????????????????????

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