ASEAN Harmonization of Evaluation of TM and HS


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18 February, 2012

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ASEAN Harmonization of Evaluation of TM and HS

  1. 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. 2. ASEAN integration For a single market By 2015 Health care sector: services and products Products: medicines, devices, traditional medicines, health supplements, cosmetics
  3. 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. 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. 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. 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. 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. 8. Guidelines: Quality andsafety Limits of contaminants: Heavy metals Mercury, lead, cadmium, arsenic WHO limits Copper removed from list
  9. 9. Guidelines: Quality andsafety Limits of contaminants: Pesticide residue Task force: Malaysia, Indonesia, Thailand, Vietnam
  10. 10. Guidelines: Quality andsafety Limits of contaminants: Microbial contamination British Pharmacopeia WHO
  11. 11. Guidelines: safety Maximum levels of vitamins and minerals WHO
  12. 12. Guidelines: safety Negative list of active ingredients
  13. 13. Guidelines: safety Restricted additives and excipients
  14. 14. Guidelines: quality Good manufacturing practice Stability
  15. 15. Guidelines: miscellaneous Claims requirements Safety and efficacy requirements Product dossier submission Labelling
  16. 16. Guidelines Quality Safety Rational use
  17. 17. Thank you !
  18. 18. Coconut Cocos nucifera
  19. 19. Moringa Moringa oleifera