ASEAN harmonization of ASEAN harmonization of ASEAN harmonization of ASEAN harmonization of ASEAN harmonization of ASEAN harmonization of ASEAN harmonization of ASEAN harmonization of evaluation of traditional evaluation of traditional evaluation of traditional evaluation of traditional evaluation of traditional evaluation of traditional evaluation of traditional evaluation of traditional medicines and health medicines and health medicines and health medicines and health medicines and health medicines and health medicines and health medicines and health supplements supplements supplements supplements supplements supplements supplements supplements ISIDRO C SIA ISIDRO C SIA Institute of Herbal Medicine, National Institutes Institute of Herbal Medicine, National Institutes of Health, University of the Philippines Manila of Health, University of the Philippines Manila 2012 February 18, Sulo Hotel, Quezon City 2012 February 18, Sulo Hotel, Quezon City
1. ASEAN harmonization ofevaluation of traditionalmedicines and
healthsupplements 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 medicineTMHS 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 medicineInterpretative notes of the
definitionTMHS 5th meeting, 2006, SingaporeINCLUDE 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 medicineInterpretative notes of the
definitionTMHS 5th meeting, 2006, SingaporeEXCLUDE 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 meeting2006 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 andsafety Limits of contaminants: Heavy
metals Mercury, lead, cadmium, arsenic WHO limits Copper removed
from list
9. Guidelines: Quality andsafety Limits of contaminants:
Pesticide residue Task force: Malaysia, Indonesia, Thailand,
Vietnam
10. Guidelines: Quality andsafety 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