International Regulatory Cooperation on Proper Use of Traditional Medicine
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International Regulatory Cooperation on Proper Use of Traditional Medicine
اسلاید 1: www.tabaye.ir
اسلاید 2: Dr Xiaorui Zhang CoordinatorTraditional MedicineDepartment of Essential Drugs and Traditional Medicine World Health OrganizationInternational Regulatory Cooperation on Proper Use of Traditional Medicine
اسلاید 4: Populations using TM/CAM worldwidePopulations using traditional medicine for primary health careEthiopiaBeninIndiaRwandaTanzaniaUgandaPopulations in developed countries who have used complementary and alternative medicine at least onceCanadaAustraliaFranceUSASources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001;World Health Organization, 1998; and government reports submitted to WHO.Germany
اسلاید 5: Duration: at least 13 yearsCost: at least US$ 100 millionProcedure for developing a new chemical drug
اسلاید 6: Reported by Prof Yeeng -chi Cheng, Yale Medical School 2001The combination of 4 plants creates powerful synergy for maximum anti-tumour effectDifficulty for evaluation of herbal medicinesRemoving any one of the 4 plants weakens the effectiveness of the formula
اسلاید 7: Major problems of international herbal marketsQuality problems Quality inconsistence Use wrong species Labelling problem lack precautionsIncluding heavy metalsIncluding chemical substance or illegal substance without announcementOther problemsLack 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
اسلاید 8: WHO Global Survey and Database of National Policy and Regulation of TM/CAMWHO Global Survey and Database of National Policy and Regulation of TM/CAM and Herbal Medicines including information from 141 countries, 2004Summary report of the global survey on national policy on traditional medicine and regulation of herbal medicines 2005
اسلاید 9: Number of Member States with Recently Established Herbal Medicines Law or RegulationNumber of Countries before 1986: 14Number of Countries Total: 8365% of respondents have established herbal medicines law or regulation42 (49%) declared regulations were in the process of being developed.
اسلاید 10: 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
اسلاید 11: Types of claims allowed for herbal medicinesRespondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents
اسلاید 12: Main Difficulties Regarding Regulatory Issues on Traditional Medicines
اسلاید 13: Why need to set up the TMHS-PWGASEAN 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) Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)
اسلاید 14: 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 guidelinesEnhance the technical infrastructure including mutual confidence in testing and conformity assessmentIdentify areas for possible harmonization and MRAsObjectivesTraditional Medicines & Health Supplements Product Working Group (TMHS – PWG)
اسلاید 15: 1. ASEAN consensus on specific area of technical requirements for harmonization, achievedOBJECTIVE 11.1.Exchange of information and analysis of the existing standard definition, terminologies, regulation & procedures amongst ASEAN Member Countries1.3.Specified areas on the technical requirements for harmonization agreed upon among Member Countries1.2. Comparative study on International and other regional technical requirements for TMHS, conductedTemplate for exchange of information developed and agreed upon.Technical requirements (including terminology and definition) of Member Countries compiled and analyzedProfile of Technical requirements of Member Countries developedTerminology and definition on TMHSstandardized in ASEANTechnical Requirementsand guidelines of international and other regionalorganization compiled, compared and analyzedTechnical requirementsof selected other countries compiled, compared and analyzedAppropriate model for ASEAN recommendedSpecific Areas for Harmonization identified and agreed upon STRATEGIESEXPECTED OUTPUTSWorking programme of ASIAN TMHS – PWG
اسلاید 16: 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)Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)
اسلاید 17: 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. Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)
اسلاید 18: 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;andTo address lack of standards in areas of public health importance to regulatory agencies.
اسلاید 19: Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Standing Committee Sub-committee IIQuality Assurance & Information Sub-committee INomenclature & StandardizationValidated Analytical MethodNomenclatureChemical Reference Standards and Reference of Medicinal Plant Materials Testing method in MonographInformation on General testGood Manufacturing PracticeGood Agricultural PracticeAdverse Drug Reaction, Sub-committee IIISecretariat (Provisional)Hong KongEWGEWGEWGEWGEWGEWGEWG
اسلاید 20: European Union1. 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
اسلاید 21: Committee on Herbal Medicinal ProductsAustriaFrance Lithuania SloveniaEstonia Germany Luxembourg SpainBelgiumGreece Malta SwedenCyprus Hungary Netherlands United Kingdom Czech Rep. Ireland Poland Denmark Italy Portugal Finland Latvia Slovak Republic EEA Members:Norway, IcelandObserver: EDQM/Europ. Pharm.Romania; Bulgaria
اسلاید 22: EU Council: a European approach to non-conventional medicine resolution 1026, 1999EU Commission: the Directive 2001/83/EC as regards traditional medicinal products, amended by 2004EMEA: the evidence of safety and efficacy required for well-established herbal medicinal products in bibliographic application 1999EMEA: the implementation of different levels of scientific evidence in core-data for herbal drugs 2003Legal and technical requirements for herbal medicines
اسلاید 23: Marketing Authorisation of Herbal Medicinal Products in the EUNational AuthorisationDirective 2001/83/EC of 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 authorizations Decentralized marketing authorizations
اسلاید 24: Member States needs for WHO Support 127116117117110105
اسلاید 25: WHO Working group meeting on international regulatory cooperation on herbal medicinesWHO 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)
اسلاید 26: International regulatory Cooperation on Herbal Medicines (IRCH)Objectivesglobally 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.
اسلاید 27: International regulatory Cooperation on Herbal Medicines (IRCH)Initial scope of activities of IRCHIRCH 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
اسلاید 28: Conclusion Status and regulation of herbal medicines vary between country to countryThe 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 medicine
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