International Regulatory Cooperation on Proper Use of Traditional Medicine

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International Regulatory Cooperation on Sy World Health peer a ‏سر‎ ۷۹۹ Organization 

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Cooperation on Proper Use of Traditional Medicine World Health Organization 

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Se cece ony World Health regulation a ۳ eee Eee eT eee Organization 

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Populations using TM/CAM worldwide 66 a feds rare 8 ۶ 8 1 1 i 3 World Health Organization 3 0 

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Procedure for developing a new chemical drug (Sek Phase i ATLEAST S YEARS 

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۱۱۸۱۱۱۱۵۱۱۱۵۵۱۵۱ ‏ار‎ ‎medicines PHY906 on CPT-11 Antitumor Effect in BDF-1 Mice Bearing Colon 38 Tumor ‎any‏ دی ‎ ‏ده لغ ۱۱۱ 

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Major problems of international — ‏ل ال‎ 5500 ار ری واه *Use wrong species *Labelling Pen criy ا Including heavy metals *Including chemical substance ‏تا(‎ substance without announcement تفت بر صملا م مصمكسذ سمغ هص عذوع2 و ‎١‏ ‏ا ا ا ا ‎countries‏ Lack producer information in the original countries »Lack communication between national TRE authorities of preterm eared ‏درو‎ ‎202223 @ World Health ‏ی وی مرس سید سای تج‎ Organization 

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O 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 ‏آمدمنامه جهن زمنسیای تقطامان‎ policy on traditional medicine and regulation of herbal medicines 2005 Crea nee eee @ World Health ‏جر‎ neg 0011 Organization 

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Number of Member states with hecently, Established Herbal Medicines Law or BCE aCe CO ‏لك‎ ۶ ووم0۳06 سم هم ۳-3 و ‎being‏ 5655 6 | 5658 او © | هو | 100 i 3 ا يي ةك حت ی 01000002000 lation @ World Health ‏ی‎ Organization 

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لا ‎ate‏ ,۱ سای دس سل رشب medicines ] (oer ones em OuNe) ‏سب‎ رادم دو و و ات ‎ee a ke eee eee‏ ee ‏بوره‎ ada ‏4و6 امس‎ 0 0 ور coy 60 ۰ 0 0 0 00 0 RON et Oa Respondents were able to answer with more ‏م ره‎ number exceeds number of respondents 0 ‏سنا‎ World Health regulation oath ‏و در‎ mee Tyree Tere Organization 

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Types of claims allowed for herbal, medicines واه اوواووه ‎Ouneat‏ ] end ها و الم موه علوت ۱ ندا سار 0 ‏ا يك‎ iad ia aeceee had aca hoc ee ee eee Cero eee! World Health regulation a ۳ eee Eee eT eee Organization 

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Main Difficulties Regarding Regulatory Issues on Traditional Medicines Ne det alee h اه مه هرت ۱3 ملس مت ل ‎ee dee‏ تمد ما ۱3 ‏لته تمهت‎ felt ig Cee ay eer ee eee 

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Traditional Medicines & Health © Supplements Product Working Group (TMHS - PWG) ‎Raa a CMa tee le)‏ وط۲ ‎* 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. ‎8 11 ‏لفل ل اك ا ل ا ا ا‎ challenges, ASEAN leaders have also approved to ‏و۱‎ ete Bee eC (Ure ete tA sectors in 2010 which include Traditional Medicines and Health Supplement Products and formed a Product Working Group > Traditional Medicines & ‎Bie ia‏ و ‎International Regulatory Cooperation on World Health regulation Organization ۳ eee Eee eT eee 

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Traditional Medicines & Health oe 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 ‏بات‎ Enhance the technical infrastructure 3 ۰ a ‏ای ات۳‎ mutual confidence in testi Health AMONG LIAM ‏۲صمصصوع‎ Organization 

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Working programme OF ASLAN ۱۷۱۸۵ - PWG 1. ASEAN consensus on specific area of technical OBJECTIVE 2 ; ane : requirements for harmonization, achieved ‏موس سم موس‎ Information and study on an the technical ۳ ‏تس مس‎ ۳ for STRATEGIES | ‏مت‎ ‏ی‎ ens poor ene Serge ASN ‏سم‎ ‎enter ‏سس‎ ‎EXPECTED OUTPUTS: ‘Template ‏ی خی بو تج المع ال‎ te ‏ات‎ ooy ‏سم سس‎ ‘reas for ‏ا سح‎ nn stan Harmonie “developed Counties fl Sea ‏مس‎ oo one developed | complied, سم تس 

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Ce Ahern wea ‏مه ی‎ 62) ۱ = 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. « ‏حدمنام2تصمحصحقط ص دمتاهومممن بوع عمط م وز معط[‎ ‏لك‎ تا ل لاف ل اا ا ل ايت 0 ۱۳۱ ‏این‎ 2. China World Health Organization ۳ eee Eee eT eee 

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212110 عط :101 ستحرهظ ‎of Herbal Medicines (FHH)‏ ۱ waste Western Pacific Regional IG] 5 = 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. World Health Organization 

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‎ated 5‏ و فد میک لفیا ‎for the Harmonization of Herbal‏ ‎Medicines (FHH) 62)‏ ‎= 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. ۳ ‏رو ام‎ ry World Health ation Organization ‏وم ‎eee Eee eT eee‏ ۳ 

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Western Pacific Regional Forum | 3 for the Harmonization of Herbal| Secretariat (Provisional ) Hong Kong Sub-committee Quality Assurance & Information Good Agricultural Practice EWS Good Manufacturing Practice 6 Adverse Drug Reaction, Sub-committee II ‎(FHH)‏ و موی ‎ ‎Standing Committee ‎ ‎Sub-committeeI ‎Nomenclature & Standardization ‎ ‎NomenclatureEWG ‎ ‎Information on General test 2wg ‎Validated Analytical Metho@Ws ‎Testing methodin Monograpkiws ‎| EWG ‎World Health Organization ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ 

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European Union ۳ * oad <7 10 1. European Parliament (representation of the will of the EU citizens; legislative power; control over community institutions) 2. European ‏و9(‎ ‎Commission the EU (executive body) (legislative body) Agencies of the MS and of the European Union (EMEA) Gpevitc Cowwiters va Werbd Ordctad Products مه د سه ‎yeep‏ ‎Organization‏ تسعد ات ۳ eee Eee eT eee 

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Committee on Herbal Medicinal Products ۱۱ ‏امین‎ France Lithuania ICT) POR ey Germany Luxembourg 2 Belgium Greece Malta Sweden Cyprus Hungary Netherlands United Kingdom Czech Rep. Ireland Denmark _ Italy | ‏ی تا‎ Norway, Iceland | International Regulatory Cooperation on regulation ۳ eee Eee eT eee 

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Legal and technical ks a ad کیب اواتعظ ۲0۲ ال ا ‎Xe heptane)‏ ‎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 Rory aa ‏هه 09 ای یت ار‎ aa ۳۳ ۳ ee ee ee es 

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۱۸۲۱ ‏ا ل‎ >: of Herbal Medicinal ae Products in the EU ۱۱ ۱۱ unc) Directive 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 ۱ ‏ا الات‎ 7 ‏ا ا‎ ent ae ‏ا سسا‎ of herbal medicines 29 Mat 

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Member ‏پآ‎ ‎Support Cee ene eed 127 Se eC 116 Cave hunt ape ‏اتج تمواق‎ 17 0 0 ee ee cee 110 Co iene 105 ‏اه‎ ‎ea ‏لنت كك‎ OMS UMC CS RCO) 00 ۱ ۷۷۵۲۵ 6۵۱ sie arora Organization poy ‏یسیو‎ ene eee eT 

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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 peace LT = regulatory authorities representing each of the 6 oe ey kes tee CUNO 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) International Regulatory Cooperation on World Health ‏سس‎ 2 ‏ی‎ Organization 

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Sigurt Bac tC a on Herbal Medicines (IRCH) aa) = globally promote and facilitate the safe use of herbal ‏اه بل جیپ ی بت سم‎ nae through sharing information ‏ا‎ : pene to TR cc a Fe ear و ‎ae ee‏ و ‎one ee ages‏ ‎= further share research and knowledge of traditional ‏یات‎ duplication; ‏ات۱ ‏ل لاي یات تیا سید را ‎safe use of herbal medicines;‏ ماب م1 ۲۵۵۸ مء ومیاووز ‎recommend‏ = وتات بخ تن 16 زور۱ تع © | ‎Organization‏ ص ا و در 

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‎A‏ اه ‎Cooperation on Herbal‏ ‎Medicines (IRCH)‏ ‎Initial scope of activities of IRCH‏ ‎IRCH is in the initial stages. There are two ‎main activities: ‎۶ ‏یمام احمتصطهما صه مصتتعطای ممتتمرم]د]‎ related to regulatory information of ‏#ااره تاد اد لاا‎ communication as the main tool, on a daily basis, through an Information Focal ۱ ‏تا ار تاینن‎ ace ‏ا رف را تا‎ of IRCH. ‎=Convening annual meetings of IRCH. ‏کت ان ‎Second‏ ‏کی ی ی ‏ی ‎ene ۵‏ ی ‎oY Organization‏ ۱ 2 ‎ 

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Conclusion = Status and regulation of herbal medicines vary ‏اكتأصتامه ما اككستامء عع راعط‎ ‎gts (od‏ ا ل ل و ما1 ‎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 ‎World Health Organization ‎