18 February, 2012

1. ASEAN harmonization of
evaluation of traditional
medicines and health
supplements
ISIDRO C SIA
Institute of Herbal Medicine, National Institutes
of Health, University of the Philippines Manila
2012 February 18, Sulo Hotel, Quezon City

2. ASEAN integration
For a single market
By 2015
Health care sector: services
and products
Products: medicines, devices,
traditional medicines, health
supplements, cosmetics

3. ASEAN integration
ACCSQ ASEAN Consultative Committee
on Standards and Quality
ACCSQ TMHS PWG Traditional
Medicines – Health Supplements Product
Working Group
ATSC ACCSQ Technical and Scientific
Committee

4. Traditional medicine
TMHS 4th meeting, 2006, Thailand
Any medicinal product for human use
consisting of active ingredients derived
from natural sources (plants, animals
and/or minerals) used in the system of
traditional practice
Should not include any sterile preparation,
vaccines, any substance derived from
human parts, any isolated and
characterized chemical substances

5. Traditional medicine
Interpretative notes of the definition
TMHS 5th meeting, 2006, Singapore
INCLUDE
Categories:
Categories: TM from ASEAN and outside ASEAN countries such
as TCM, ayurveda, herbal products/ medicines, homeopathic
medicines
Active ingredients: From natural sources (plants, animals,
ingredients:
minerals, or combinations); standardized herbal extracts
Intended uses
- Maintenance and promotion of health: to be supported by
evidence of traditional use or empirical use (in formulation or
ingredients)
- Traditional usage: use in the system of traditional practice, the
sum of knowledge, skills and practice based on the theories and
experiences indigenous to different cultures
- Medicinal purposes [cure or treatment, prevent disease;
alleviate symptoms]: claims may be low, medium or high level

6. Traditional medicine
Interpretative notes of the definition
TMHS 5th meeting, 2006, Singapore
EXCLUDE
Active ingredients:
- Negative list (ie, potent or toxic constituents)
- Substances exceeding stipulated limits
- Narcotics and psychotropics
Others:
Others:
- Sterile preparations (ie, injection, eye preparation)
- Vaccines
- Human parts and derivatives
- Isolated and characterized chemical substances
- Products in food presentation including beverages

7. Health supplement TMHS 5th meeting
2006 Singapore
Any product that is used to supplement a diet and to
maintain, enhance and improve the healthy function of the
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 form of
extracts, isolates, concentrates and metabolites
c. Synthetic sources of ingredients mentioned in a) and b)
may only be used where the safety of these has been
Presented in dosage forms to be administered in small unit
doses such as capsules, tablets, powder, liquid
Shall not include any sterile preparations, ie, injectables

8. Guidelines: Quality and
safety
Limits of contaminants: Heavy
metals
Mercury, lead, cadmium,
arsenic
WHO limits
Copper removed from list

9. Guidelines: Quality and
safety
Limits of contaminants:
Pesticide residue
Task force: Malaysia,
Indonesia, Thailand, Vietnam

10. Guidelines: Quality and
safety
Limits of contaminants:
Microbial contamination
British Pharmacopeia
WHO

11. Guidelines: safety
Maximum levels of vitamins
and minerals
WHO

12. Guidelines: safety
Negative list of active
ingredients

13. Guidelines: safety
Restricted additives and
excipients

14. Guidelines: quality
Good manufacturing practice
Stability

15. Guidelines: miscellaneous
Claims requirements
Safety and efficacy requirements
Product dossier submission
Labelling

16. Guidelines
Quality
Safety
Rational use

17. Thank you !

18. Coconut Cocos nucifera

19. Moringa Moringa oleifera