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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 l.jpg

International Regulatory Cooperation on Proper Use of Traditional Medicine

Dr Xiaorui ZhangCoordinator

Traditional Medicine

Department of Essential Drugs and Traditional MedicineWorld Health Organization


Populations using tm cam worldwide l.jpg

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.


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Procedure for developing a new chemical drug

Duration: at least 13 years

Cost: at least US$ 100 million


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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


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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


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    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


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    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


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    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


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    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


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    Main Difficulties Regarding Regulatory Issues on Traditional Medicines


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    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)


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    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


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    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


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    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)


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    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.


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    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.


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    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


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    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


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    Committee on Herbal Medicinal Products

    • AustriaFrance Lithuania Slovenia

    • Estonia Germany Luxembourg Spain

    • BelgiumGreece 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


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    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


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    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


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    Member States' needs for WHO Support

    127

    116

    117

    117

    110

    105


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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 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)


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    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.


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    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


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    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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