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1 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 Briefing on TBS Training course 18 Sep 2006 Geneva 2 Populations using TM/CAM worldwide Ethiopia Populations using traditional medicine for primary health care Populations in developed countries who have used complementary and alternative medicine at least once 90% Benin 70% India 70% Rwanda 70% Tanzania 60% Uganda 60% Germany 80% Canada 70% France 49% Australia 48% USA 42% Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001; World Health Organization, 1998; and government reports submitted to WHO. Briefing on TBS Training course 18 Sep 2006 Geneva 3 Germany & France dominate on European herbals market Total Market 09/2003-09/2004: ~ 3.7 billion € ex-factory 2% 2% 2% GERMANY 11% FRANCE 39% 4% ITALY POLAND UK 5% SPAIN 6% SWITZERLAND BELGIUM 8% 21% NETHERLANDS OTHERS Briefing on TBS Training course 18 Sep 2006 Geneva 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) 37% 63% Western Medicines - RMB 144.6 billion (USD 17.6 billion) Briefing on TBS Training course 18 Sep 2006 Geneva TCM Western Medicines 5 Projected Worldwide Growth of Herbal Remedies Until 2006 25.0 + 2.4%/a 20.0 + 8.5%/a 15.0 10.0 5.0 0.0 2000 2001 2002 Sports/Specialty Briefing on TBS Training course 18 Sep 2006 Geneva 2003 2004 Herbals 2005 VMS 2006 Sources: Phytopharm Consulting, Datamonitor 30.0 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 9 Procedure for developing a new chemical drug Duration: at least 13 years Cost: at least US$ 100 million Briefing on TBS Training course 18 Sep 2006 Geneva Evaluation of Efficacy of Herbal Medicines The combination of 4 plants creates powerful synergy for maximum anti-tumour effect 10 Removing any one of the 4 plants weakens the effectiveness of the formula Reported by Prof Yeeng -chi Cheng, Yale Medical School 2001 Briefing on TBS Training course 18 Sep 2006 Geneva 11 WHO Traditional Medicine Strategy 2002-2005 1 Policy: 2 Safety, efficacy and quality: 3 Access: 4 Rational use: Briefing on TBS Training course 18 Sep 2006 Geneva integrate TM/CAM with national health care systems provide evaluation, guidance and support for effective regulation ensure availability and affordability of TM/CAM, including essential herbal medicines 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 14 Challenges of definition of herbal medicines Definition 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. Briefing on TBS Training course 18 Sep 2006 Geneva 15 Number of Member States with Recently Established Herbal Medicines Law or Regulation 16 65% of respondents have established herbal medicines law or regulation 14 12 10 8 6 42 (49%) declared regulations were in the process of being developed. 4 2 0 Before 1986 - 1988 - 1990 - 1992 - 1994 - 1996 - 1998 - 2000 - 2002 1986 1987 1989 1991 1993 1995 1997 1999 2001 2003 14 4 5 2 8 7 Number of Countries before 1986: 14 Number of Countries Total: Briefing on TBS Training course 18 Sep 2006 Geneva 83 13 16 9 5 16 Types of herbal medicines regulation The law or regulation for herbal medicines is partly the 43 Separate law or regulation for herbal medicines 22 Same law or regulation as for conventional pharmaceuticals 46 0 10 20 30 40 Number of Countries Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents Briefing on TBS Training course 18 Sep 2006 Geneva 50 17 Regulatory status of herbal medicines Prescription medicines 50 Over the Counter Medicines (O.T.C) 99 Dietary Supplements 48 Self-medication only Herbal Medicines as a separate regulatory category Health Food 39 30 16 Functional Food 10 Other 12 No Status 21 0 20 40 60 80 100 Number of Countries Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents Briefing on TBS Training course 18 Sep 2006 Geneva 120 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva 20 Types of claims allowed for herbal medicines Medical claims 91 Health claims 62 Nutrient content claims 50 Structure/function claim 40 Other claims 7 No claims can be made according to the law 5 0 Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents Briefing on TBS Training course 18 Sep 2006 Geneva 20 40 60 80 Number of Countries 100 21 What is "evidence" in the field of medicine? Randomized selection, Double-blinded, Placebo-controlled trials. A A. Randomized Controlled Trials (RCT) B B. Well-conducted Clinical Studies 14% C. Expert Committee Reviews or the clinical experience of respected authors. 28% C 8% “Using Clinical Guidelines to Improve Patient Care within the NHS "1996 Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 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) Briefing on TBS Training course 18 Sep 2006 Geneva 24 Number of Registered Herbal Medicines 18 16 14 12 Number of 10 Countries 8 6 4 2 0 1-50 51-100 101200 201300 301500 5001000 1000 and 18 8 9 5 4 4 18 Number of Herbal Medicines Registered Number of Countries Total: 66 Briefing on TBS Training course 18 Sep 2006 Geneva 25 Number of Member States with Regulatory Requirements for Good Manufacturing Practice Same rules of good manufacturing practice Adherence to information in 73 59 30 Special GMP rules 28 No requirements 15 Question not answered 6 Other Namely 0 20 40 60 80 Number of Member States Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva 27 Main Difficulties Regarding Regulatory Issues on Traditional Medicines 102 Lack of research data Lack of appropriate control mechanisms 88 Lack of education and training 81 64 Lack of expertise Other Briefing on TBS Training course 18 Sep 2006 Geneva 33 28 Member States' needs for WHO Support 83 Information-sharing on regulatory issues 68 Herbal medicine safety monitoring workshops General guidelines on research and evaluation of herbal medicines 67 Herbal medicine regulation workshops 66 Global meetings Not needed 47 50 44 50 Other 16 0 55 12 127 7 116 5 117 3 9 117 110 105 80 20 40 60 80 100 120 140 Number of Member States Briefing on TBS Training course 18 Sep 2006 Geneva 4 48 70 Provision of databases Much needed Needed 44 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, Lao, Malaysia, Philippines, Singapore, Vietnam Briefing on TBS Training course 18 Sep 2006 Geneva Indonesia, Myanmar, Thailand, 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) Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva Working programme of ASIAN TMHS – PWG 1. ASEAN consensus on specific area of technical requirements for harmonization, achieved OBJECTIVE 1 STRATEGIES 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 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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 33 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) Briefing on TBS Training course 18 Sep 2006 Geneva 34 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. Briefing on TBS Training course 18 Sep 2006 Geneva 35 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. Briefing on TBS Training course 18 Sep 2006 Geneva 37 Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Standing Committee Secretariat (Provisional) Hong Kong Sub-committee I Nomenclature & Standardization Sub-committee II Quality Assurance & Information Nomenclature EWG Information on General testEWG Validated Analytical MethodEWG Testing method in Monograph EWG Good Agricultural Practice EWG Good Manufacturing Practice EWG Adverse Drug Reaction, Subcommittee III EWG Chemical Reference Standards and Reference of Medicinal Plant Materials Briefing on TBS Training course 18 Sep 2006 Geneva 38 European Union 1. European Parliament (representation of the will of the EU citizens; legislative power; control over community institutions) 2. European Commission 3. Council of the EU (executive body) (legislative body) Agencies of the MS and of the European Union (EMEA) Specific Committee on Herbal Medicinal Products Briefing on TBS Training course 18 Sep 2006 Geneva 39 Committee on Herbal Medicinal Products Austria Estonia Belgium Cyprus Kingdom Czech Rep. Denmark Finland France Germany Greece Hungary Lithuania Luxembourg Malta Netherlands Ireland Italy Latvia Poland Portugal Slovak Republic EEA Members: Norway, Iceland Observer: Pharm. Slovenia Spain Sweden United EDQM/Europ. Romania; Bulgaria Briefing on TBS Training course 18 Sep 2006 Geneva 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 Registration (well-established use) 3. Simplified dossier for traditional products Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 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). Briefing on TBS Training course 18 Sep 2006 Geneva 45 PAHO/WHO and PANDRH 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; WHO Mandate: 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 Briefing on TBS Training course 18 Sep 2006 Geneva 46 PANDRH Structure and Operating System Regulators Andean Area CARICOM MERCOSUR SICA NAFTA INDUSTRY Pan American Conference Secretariat Steering Committee Consumers Academia Professional Ass WG WG WG WG WG WG Briefing on TBS Training course 18 Sep 2006 Geneva 47 Organization of PADRH NRA Members NA: Mexico CA*: Costa Rica CR*: Trinidad &Tobago ME*: Argentina AA: Colombia Pharmaceutical Industry One rep from FIFARMA One rep from ALIFAR Briefing on TBS Training course 18 Sep 2006 Geneva Alternate USA Panama Barbados Chile Bolivia ------------------------- 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. Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 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/subregional/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) Briefing on TBS Training course 18 Sep 2006 Geneva 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. Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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 Briefing on TBS Training course 18 Sep 2006 Geneva 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/medicines/areas/traditional/en/index.html http//www.who.int E-mail: [email protected] Briefing on TBS Training course 18 Sep 2006 Geneva