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Dr Xiaorui Zhang Coordinator

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1 Dr Xiaorui Zhang Coordinator
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

2 Populations using TM/CAM worldwide
Populations using traditional medicine for primary health care Ethiopia Benin India Rwanda Tanzania Uganda Populations in developed countries who have used complementary and alternative medicine at least once Canada Australia France USA 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 Germany & France dominate on European herbals market
Total Market 09/ /2004: ~ 3.7 billion € ex-factory Source: IMS 2005

4 Herbal Market in China (2004)
Annual Sales Comparison between Traditional Chinese Medicines and Western Medicine TCMs (Preparations & Processed Products) - RMB 84.9 billion (USD 10.3 billion) Western Medicines - RMB billion (USD 17.6 billion)

5 Projected Worldwide Growth of Herbal Remedies Until 2006
Sources: Phytopharm Consulting, Datamonitor

6 Traditional medicine contribute to health
Artemisinin is a new anti-malarial drug. It was discovered from Artemisia annua L. which is traditionally used Chinese medicine for treatment of malaria and other health problems. WHO recommends to use Artemisinin based combined therapy (ACT) for the treatment of falciparum malaria since 2002 Currently, Tamiflu is the only drug for avian influenza. It is based on shikimic acid which is abstracted from plant Illicium lanceolalum, which is also one of traditionally used Chinese medicines

7 Difficulties Specific to TM/CAM Research
Characteristics of Western Medicine The main philosophy of Western Medicine is that if the human body is struck by diseases, the causative agent must be identified and dealt with in order to return patients to a state of good health.

8 Difficulties Specific to TM/CAM Research
A common feature of most systems of Traditional Medicine is that they take a 'holistic' approach towards the sick individual and treat disturbances on the physical, emotional, mental and living environment levels simultaneously.

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

10 Evaluation of Efficacy of Herbal Medicines
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 Reported by Prof Yeeng -chi Cheng, Yale Medical School 2001

11 WHO Traditional Medicine Strategy 2002-2005
1 Policy: integrate TM/CAM with national health care systems 2 Safety, efficacy and quality: provide evaluation, guidance and support for effective regulation 3 Access: ensure availability and affordability of TM/CAM, including essential herbal medicines 4 Rational use: promote therapeutically-sound use of TM/CAM by providers and consumers

12 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 medicines 2005

13 WHO Global Survey and database of traditional medicine
Objectives To collect updated and comprehensive information on TM/CAM policies and regulations of herbal medicines to make analysis on the current situation and major challenges To clarify what are specific needs on capacity building regarding TM/CAM and regulations of herbal medicines and what directed support WHO should provide to the Member States accordingly. r To update the document “Regulatory Situation of Herbal Medicines- a world wide review”. To monitor the impact of the WHO Strategy for Traditional Medicine in relation to present national policy and regulation on TM/CAM/herbal medicines.

14 Challenges of definition of herbal medicines
Finished herbal products Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb is used, the term mixture herbal product can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal. Recommendation from workshop of herbal medicines, 11th ICDRA, 2002 Member States should strengthen the post-marketing surveillance system of herbal medicines. Particular attention should be given to the possible adulteration of herbal medicines by chemicals or other ingredients which have not been labelled.

15 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:

16 Types of herbal medicines regulation
Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents

17 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

18 Challenges of regulatory status of herbal medicines
e.,g Garlic If Garlic intends to be used as food spice, it is food, but if it is used to stop diarrhoea, it is herbal medicines Garlic gel is categorised a herbal medicine product in Germany Garlic gel is categorised a food supplement in UK and USA Garlic gel is categorised a health food in Japan

19 Challenges of regulatory status of herbal medicines
It is difficult to distinguish between herbal medicines and health food or diet-supplement Definition depend on countries own used experience Definition highly depend on labeling and intended use (claims) Highly depend national regulation of food and medicines Clinical or bibliographic data on efficacy could refer to regulate products into diet-supplement or medicine categories

20 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

21 What is "evidence" in the field of medicine?
Randomized selection, Double-blinded, Placebo-controlled trials. A Randomized Controlled Trials 8% (RCT) Well-conducted Clinical % Studies Expert Committee Reviews % or the clinical experience of respected authors. B C “Using Clinical Guidelines to Improve Patient Care within the NHS "1996

22 Level of evidence requirement (Australia)
Level of claim Type of claim Evidence required of support claim HIGH Treats/cures/manages any disease/disorder. Prevention of any disease or disorder. Treatment of vitamin or mineral deficiency diseases. High level. Registration only –evaluated by the CMEC, MEC (Medicines Evaluation Committee) or the ADEC (Australian Drug Evaluation Committee). MEDIUM Health enhancement2. Reduction of risk of a disease/disorder. Reduction in frequency of a discrete event. Aids/assists in the management of a named symptom/disease/disorder.Relief of symptoms of a named disease or disorder3. Medium level. Sponsor must hold the evidence for Listable goods. GENERAL Health maintenance, including nutritional support.Vitamin or mineral supplementation4. Relief of symptoms (not related to a disease or disorder)3. General level. Sponsor must hold the evidence for Listable goods.

23 Level of evidence required for the regulation of TM/CAM
Two types of evidence which can be used to support claims (EU) scientific evidence evidence based on traditional use of products, which have been on the market for at least 30 years without any risks reported. (15 years within European countries and 15 outside European countries)

24 Number of Registered Herbal Medicines
Number of Countries Total: 66

25 Number of Member States with Regulatory Requirements for Good Manufacturing Practice

26 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

27 Main Difficulties Regarding Regulatory Issues on Traditional Medicines

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

29 ASEAN Regulatory Cooperation for Herbal Medicine
ASEAN Consultative Committee for Standards And Quality (TMHS- PWG, ACCSQ) TMHS-PWG formed in August 2004 to implement measures on TM & HS under Healthcare integration roadmap Chaired by Indonesia Co-chaired by Malaysia Member countries (10 countries) Brunei Darussalam, Cambodia, Indonesia, Lao, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam

30 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)

31 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

32 ASEAN Regulatory Cooperation for Herbal Medicine
TMHS-PWG meets 2 x/year and to date 3 meeting had been conducted Certain member countries is assigned to further review, study and analyzes technical requirement on specific areas which will then be discussed during the meeting and or distributed between the meeting to member countries for further comments

33 Working programme of ASIAN TMHS – PWG
1. ASEAN consensus on specific area of technical requirements for harmonization, achieved OBJECTIVE 1 1.1. Exchange of information and analysis of the existing standard definition, terminologies, regulation & procedures amongst ASEAN Member Countries 1.2. Comparative study on International and other regional technical requirements for TMHS, conducted 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

34 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 China 3. Japan Republic of Korea 5. Singapore Viet Nam 7. Hong Kong (SAR China)

35 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.

36 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.

37 Secretariat (Provisional)
Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Secretariat (Provisional) Hong Kong Standing Committee Sub-committee I Nomenclature & Standardization Sub-committee II Quality Assurance & Information 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 Chemical Reference Standards and Reference of Medicinal Plant Materials EWG

38 2. European Commission (executive body)
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

39 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

40 Herbal Medicinal Products in the EU Access to the market
Marketing Authorization 1. Full documentation with new tests and trials mandatory for: - any herbal medicinal product never marketed in the EU - therapeutic innovations - new indication / therapeutic area for “old” products 2. Full bibliographic documentation (well-established use) Registration 3. Simplified dossier for traditional products

41 Annex 1 to CD 2001/83 EC amended by CD 2003/63 of 25 June 2003
“well-established medicinal use” Annex 1 to CD 2001/83 EC amended by CD 2003/63 of 25 June 2003 (a) Factors which have to be taken into account the time over which a substance has been used quantitative aspects of the use of the substance the degree of scientific interest in the use of the substance (reflected in the published scientific literature) the coherence of scientific assessments different periods of time may be necessary for establishing ”well established use” of different substances minimum of one decade from the first systematic and documented use of that substance as a medicinal product in the EU.

42 The new simplified registration procedure
Registration of traditional herbal medicinal products applicable to traditional herbal medicinal products Article 16c 1 (c) > 30 years of medicinal use within the EU or > 15 years in and > 15 years outside the EU Deviations may be decided by the Herbal Committee if requested by a Member State

43 Third PARLATINO Inter-parliamentary Health Conference was held in Sao Paulo in 2005 and attended by 74 parliamentarians from 17 countries. The “Parliamentary Group on Traditional and Complementary Medicine” was created with the purpose of monitoring the question of legislative norms on TCM in Latin America.

44 Project Drawing up a draft framework law on traditional and complementary medicine for approval by PARLATINO (first stage). Preparation of ad hoc legislation on traditional and complementary medicine based on the framework law adopted by PARLATINO, for discussion and approval by the national congresses and legislative assemblies of the countries of Latin America (second stage).

45 PAHO/WHO and PANDRH Resolution supporting PANDRH
WHO Mandate: to act as directing and coordinating authority on international health work; and to develop, establish and promote international standards with respect to biological, pharmaceutical and similar products; PAN American Sanitary Conference supports the development of essential drug policies that include drug legislation and registration; drug manufacturing and marketing; and drug use and drug financing; that promotes the establishment of pharmaceutical services and drug information for health workers and public education promoting the rational use of medicines 42nd PAHO/WHO Directing Council: September 2000 Resolution supporting PANDRH

46 PANDRH Structure and Operating System
Pan American Conference Regulators Andean Area CARICOM MERCOSUR SICA NAFTA INDUSTRY Secretariat Steering Committee Consumers Academia Professional Ass WG WG WG WG WG WG

47 Organization of PADRH NRA Members Alternate NA: Mexico USA
CA*: Costa Rica Panama CR*: Trinidad &Tobago Barbados ME*: Argentina Chile AA: Colombia Bolivia Pharmaceutical Industry One rep from FIFARMA One rep from ALIFAR

48 Mission of ANDRAH Working Group of Herbal Medicines
To foster a common understanding of MP in the Region of the Americas and to develop recommendations to promote regulatory harmonization taking into consideration the traditional and sustainable use of Medicinal Plants.

49 Objectives of ANDRAH Working Group of Herbal Medicines
To promote and strengthen the exchange of information about MP To promote the assurance of quality, safety and efficacy of MP in the Americas, including the development of programs for vigilance and control; To develop proposals for harmonized regulatory activities in the area of MP; and to support countries in the implementation of these activities once they have been adopted by PANDRH; To promote activities and educational programs on MP for health care providers, consumers, and the public in general.

50 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)

51 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.

52 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

53 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

54 Thanks for all of your support and cooperation in the past and looking forward in the future Traditional Medicine Department of Technical Cooperation for Essential Drugs and Traditional Medicine Websites:  http//www.who.int  


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