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International Regulatory Cooperation on Proper Use of Traditional Medicine

International Regulatory Cooperation on Proper Use of Traditional Medicine. Dr Xiaorui Zhang Coordinator Traditional Medicine Department of Essential Drugs and Traditional Medicine World Health Organization. Ethiopia. Benin. Populations using traditional medicine for primary health care.

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International Regulatory Cooperation on Proper Use of Traditional Medicine

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  1. International Regulatory Cooperation on Proper Use of Traditional Medicine Dr Xiaorui ZhangCoordinator Traditional Medicine Department of Essential Drugs and Traditional MedicineWorld Health Organization

  2. Ethiopia Benin Populations using traditional medicine for primary health care India Rwanda Tanzania Uganda Populations in developed countries who have used complementary and alternative medicine at least once Canada France Australia USA Populations using TM/CAM worldwide Germany Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001; World Health Organization, 1998; and government reports submitted to WHO.

  3. Procedure for developing a new chemical drug Duration: at least 13 years Cost: at least US$ 100 million

  4. Difficulty for evaluation of herbal medicines Reported by Prof Yeeng -chi Cheng, Yale Medical School 2001 The combination of 4 plants creates powerful synergy for maximum anti-tumour effect Removing any one of the 4 plants weakens the effectiveness of the formula

  5. Major problems of international herbal markets • Quality problems • Quality inconsistence • Use wrong species • Labelling problem • lack precautions • Including heavy metals • Including chemical substance or illegal substance without announcement • Other problems • Lack registration information of products in in the original countries • Lack producer information in the original countries • Lack communication between national drug authorities of imported and exported countries

  6. WHO Global Survey and Database of National Policy and Regulation of TM/CAM • WHO Global Survey and Database of National Policy and Regulation of TM/CAM and Herbal Medicines including information from 141 countries, 2004 • Summary report of the global survey on national policy on traditional medicine and regulation of herbal medicines2005

  7. Number of Member States with Recently Established Herbal Medicines Law or Regulation 65% of respondents have established herbal medicines law or regulation 42 (49%) declared regulations were in the process of being developed. Number of Countries before 1986: 14 Number of Countries Total: 83

  8. Regulatory status of herbal medicines Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents

  9. Types of claims allowed for herbal medicines Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents

  10. Main Difficulties Regarding Regulatory Issues on Traditional Medicines

  11. Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG) Why need to set up the TMHS-PWG • ASEAN consider the need to remove technical barriers of trade in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) to realize the ASEAN Free Trade Agreement (AFTA) and to create a stable, prosperous and highly competitive ASEAN economic region. • To respond the new dynamics of the global challenges, ASEAN leaders have also approved to pursue accelerated integration of eleven priority sectors in 2010 which include Traditional Medicines and Health Supplement Products and formed a Product Working Group  Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)

  12. Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG) Objectives • Exchange, review and analyze information on the existing regulatory framework/regime including standard, definition, terminologies, and technical infrastructure in Member Countries. • Study the existing regulatory framework/regime of selected countries and internationally accepted technical guidelines • Enhance the technical infrastructure including mutual confidence in testing and conformity assessment • Identify areas for possible harmonization and MRAs

  13. Working programme of ASIAN TMHS – PWG 1. ASEAN consensus on specific area of technical requirements for harmonization, achieved OBJECTIVE 1 1.2. Comparative study on International and other regional technical requirements for TMHS, conducted 1.1. Exchange of information and analysis of the existing standard definition, terminologies, regulation & procedures amongst ASEAN Member Countries 1.3. Specified areas on the technical requirements for harmonization agreed upon among Member Countries STRATEGIES EXPECTED OUTPUTS Template for exchange of information developed and agreed upon. Technical requirements (including terminology and definition) of Member Countries compiled and analyzed Profile of Technical requirements of Member Countries developed Terminology and definition on TMHS standardized in ASEAN Technical Requirements and guidelines of international and other regional organization compiled, compared and analyzed Technical requirements of selected other countries compiled, compared and analyzed Appropriate model for ASEAN recommended Specific Areas for Harmonization identified and agreed upon

  14. Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) • Why need to set up the FHH • Traditional Chinese medicine has been commonly used and traded with similar theory system among these countries. • However, the quality standards and technical requirements in these countries vary. • There is a need for cooperation in harmonization of standards for traditional Chinese medicines. • Seven founding member parties: • 1. Australia 2. China • 3. Japan 4. Republic of Korea • 5. Singapore 6. Viet Nam • 7. Hong Kong (SAR China)

  15. Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Nature of FHH • The FHH is a technical forum involving drug regulatory authorities of founding member parties to explore the way and measures for achieving the objectives set up by founding parties. • The role of the FHH is to provide technical documents and consensus on technical issues related to safety, efficacy and quality of herbal medicine.

  16. Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) • To provide a scientific basis for improvement or development of standards in safety, quality and efficacy of herbal medicines; • To reduce duplication of efforts; • To create economic use of valuable resources;and • To address lack of standards in areas of public health importance to regulatory agencies.

  17. Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Secretariat (Provisional) Hong Kong Standing Committee Sub-committee II Quality Assurance & Information Sub-committee I Nomenclature & Standardization Nomenclature EWG Good Agricultural Practice EWG Information on General test EWG Good Manufacturing Practice EWG Validated Analytical Method EWG Adverse Drug Reaction, Sub-committee III Testing method in Monograph EWG ChemicalReference Standards and Reference of Medicinal Plant Materials EWG

  18. European Union 1. European Parliament(representation of the will of the EU citizens; legislative power; control over community institutions) 2. European Commission(executive body) 3. Council of the EU (legislative body) Agencies of the MS and of the European Union (EMEA) Specific Committee on Herbal Medicinal Products

  19. Committee on Herbal Medicinal Products • Austria France Lithuania Slovenia • Estonia Germany Luxembourg Spain • Belgium Greece Malta Sweden • Cyprus Hungary Netherlands United Kingdom • Czech Rep. Ireland Poland • Denmark Italy Portugal • Finland Latvia Slovak Republic EEA Members: Norway, Iceland Observer: EDQM/Europ. Pharm. Romania; Bulgaria

  20. Legal and technical requirements for herbal medicines • EU Council: a European approach to non-conventional medicine resolution 1026, 1999 • EU Commission: the Directive 2001/83/EC as regards traditional medicinal products, amended by 2004 • EMEA: the evidence of safety and efficacy required for well-established herbal medicinal products in bibliographic application 1999 • EMEA: the implementation of different levels of scientific evidence in core-data for herbal drugs 2003

  21. Marketing Authorisation of Herbal Medicinal Products in the EU National Authorisation Directive 2001/83/ECof the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. basis for: Mutual Recognition of marketing authorizationsDecentralized marketing authorizations

  22. Member States' needs for WHO Support 127 116 117 117 110 105

  23. WHO Working group meeting on international regulatory cooperation on herbal medicines • WHO Working group meeting on regulatory cooperation on herbal medicines in Ottawa, Canada from 28 to 30 November 2005 hosted by the Health Products and Food Branch of Health Canada. • 29 regulatory authorities from 16 countries participated, • regulatory authorities representing each of the 6 regional/sub-regional/inter-regional regulatory cooperation groups including Forum on Harmonization of Herbal Medicines (FHH), the Pan American National Drug Regulatory Authorities Harmonization (PANDRH), the European Herbal Medicines Committee, the ASEAN Product Working Group on Traditional Medicines and Health Supplements (TMHSPWG) and the Latin American Parliament (PARLATINO)

  24. International regulatory Cooperation on Herbal Medicines (IRCH) Objectives • globally promote and facilitate the safe use of herbal medicines, including through regional initiatives, through sharing information and fostering dialogue; • facilitate and strengthen cooperation between national drug regulatory authorities by sharing experience and information related to the regulation, safety and quality of herbal medicines; • further discuss existing requirements and standards to promote the regulation, safety and quality of herbal medicines; • further share research and knowledge of traditional medicines to reduce duplication; • recommend future activities to WHO related to the safe use of herbal medicines; • recommend important issues to ICDRA for further discussion related to the safe use herbal medicines.

  25. International regulatory Cooperation on Herbal Medicines (IRCH) Initial scope of activities of IRCH IRCH is in the initial stages. There are two main activities: • Information sharing on technical matters related to regulatory information of herbal medicines via electronic communication as the main tool, on a daily basis, through an Information Focal Point nominated by each Member Country of IRCH. • Convening annual meetings of IRCH. Second working group meeting will take place in October 2006, Beijing, China

  26. Conclusion • Status and regulation of herbal medicines vary between country to country • The most difficulties for national authorities are the lack of research data, the lack of appropriate control mechanisms, the lack of education and training of providers and the lack of expertise. • Information exchange and sharing national experience is crucial aspect • WHO will provide support to the international and regional regulatory cooperation for herbal medicines

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