Presentation on theme: "Dr Xiaorui Zhang Coordinator"— Presentation transcript:
1Dr Xiaorui Zhang Coordinator International Regulatory Cooperation on Proper Use of Traditional MedicineDr Xiaorui Zhang CoordinatorTraditional MedicineDepartment of Essential Drugs and Traditional Medicine World Health Organization
2Populations using TM/CAM worldwide Populations using traditional medicine for primary health careEthiopiaBeninIndiaRwandaTanzaniaUgandaPopulations in developed countries who have used complementary and alternative medicine at least onceCanadaAustraliaFranceUSAGermanySources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001;World Health Organization, 1998; and government reports submitted to WHO.
3Germany & France dominate on European herbals market Total Market 09/ /2004: ~ 3.7 billion € ex-factorySource: IMS 2005
4Herbal Market in China (2004) Annual Sales Comparison between Traditional Chinese Medicines and Western MedicineTCMs (Preparations & Processed Products)- RMB 84.9 billion (USD 10.3 billion)Western Medicines- RMB billion (USD17.6 billion)
5Projected Worldwide Growth of Herbal Remedies Until 2006 Sources: Phytopharm Consulting, Datamonitor
6Traditional 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 2002Currently, 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
7Difficulties Specific to TM/CAM Research Characteristics of Western MedicineThe main philosophy of WesternMedicine is that if the human body isstruck by diseases, the causative agentmust be identified and dealt with inorder to return patients to a state ofgood health.
8Difficulties 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.
9Procedure for developing a new chemical drug Duration: at least 13 yearsCost: at least US$ 100 million
10Evaluation of Efficacy of Herbal Medicines The combination of 4 plants creates powerful synergy for maximumanti-tumour effectRemoving any one of the 4 plants weakens the effectiveness of the formulaReported by Prof Yeeng -chi Cheng, Yale Medical School 2001
11WHO Traditional Medicine Strategy 2002-2005 1Policy:integrate TM/CAM with national health care systems2Safety, efficacy and quality:provide evaluation, guidance and support for effective regulation3Access:ensure availability and affordability of TM/CAM, including essential herbal medicines4Rational use:promote therapeutically-sound use of TM/CAM by providers and consumers
12WHO 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, 2004Summary report of the global survey on national policy on traditional medicine and regulation of herbal medicines 2005
13WHO Global Survey and database of traditional medicine ObjectivesTo collect updated and comprehensive information on TM/CAM policies and regulations of herbal medicines to make analysis on the current situation and major challengesTo 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.
14Challenges of definition of herbal medicines Finished herbal productsFinished 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, 2002Member 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.
15Number of Member States with Recently Established Herbal Medicines Law or Regulation 65% of respondents have established herbal medicines law or regulation42 (49%) declared regulations were in the process of being developed.Number of Countries before 1986: 14Number of Countries Total:
16Types of herbal medicines regulation Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents
17Regulatory status of herbal medicines Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents
18Challenges of regulatory status of herbal medicines e.,g GarlicIf Garlic intends to be used as food spice, it is food, but if it is used to stop diarrhoea, it is herbal medicinesGarlic gel is categorised a herbal medicine product in GermanyGarlic gel is categorised a food supplement in UK and USAGarlic gel is categorised a health food in Japan
19Challenges of regulatory status of herbal medicines It is difficult to distinguish between herbal medicines and health food or diet-supplementDefinition depend on countries own used experienceDefinition highly depend on labeling and intended use (claims)Highly depend national regulation of food and medicinesClinical or bibliographic data on efficacy could refer to regulate products into diet-supplement or medicine categories
20Types 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
21What is "evidence" in the field of medicine? Randomized selection, Double-blinded, Placebo-controlled trials.ARandomized Controlled Trials 8%(RCT)Well-conducted Clinical %StudiesExpert Committee Reviews %or the clinical experience ofrespected authors.BC“Using Clinical Guidelines to Improve Patient Care within the NHS "1996
22Level of evidence requirement (Australia) Level of claimType of claimEvidence required of support claimHIGHTreats/cures/manages any disease/disorder.Prevention of any disease or disorder.Treatment of vitamin or mineral deficiencydiseases.High level. Registration only –evaluated by the CMEC, MEC (Medicines Evaluation Committee) or the ADEC (Australian Drug Evaluation Committee).MEDIUMHealth enhancement2.Reduction of risk of a disease/disorder.Reduction in frequency of a discrete event.Aids/assists in the management of a namedsymptom/disease/disorder.Relief of symptoms ofa named disease or disorder3.Medium level. Sponsor must hold the evidence for Listable goods.GENERALHealth maintenance, including nutritionalsupport.Vitamin or mineral supplementation4.Relief of symptoms (not related to a disease ordisorder)3.General level. Sponsor must hold the evidence for Listable goods.
23Level of evidence required for the regulation of TM/CAM Two types of evidence which can be used to support claims (EU)scientific evidenceevidence 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)
24Number of Registered Herbal Medicines Number of Countries Total: 66
25Number of Member States with Regulatory Requirements for Good Manufacturing Practice
26Major problems of international herbal markets Quality problemsQuality inconsistenceUse wrong speciesLabelling problemlack precautionsIncluding heavy metalsIncluding chemical substance or illegal substance without announcementOther problemsLack registration information of products in in the original countriesLack producer information in the original countriesLack communication between national drug authorities of imported and exported countries
27Main Difficulties Regarding Regulatory Issues on Traditional Medicines
28Member States' needs for WHO Support 127116117117110105
29ASEAN Regulatory Cooperation for Herbal Medicine ASEAN Consultative Committee for Standards And Quality (TMHS- PWG, ACCSQ)TMHS-PWG formed in August 2004 to implement measures onTM & HS under Healthcare integration roadmapChaired by IndonesiaCo-chaired by MalaysiaMember countries (10 countries)Brunei Darussalam, Cambodia, Indonesia,Lao, Malaysia, Myanmar, Philippines, Singapore, Thailand,Vietnam
30Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG) 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)
31Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG) ObjectivesExchange, 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 MRAs
32ASEAN Regulatory Cooperation for Herbal Medicine TMHS-PWG meets 2 x/year and to date 3 meeting had been conductedCertain 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
33Working programme of ASIAN TMHS – PWG 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 Countries1.2.Comparative study on International and other regional technical requirements for TMHS, conducted1.3.Specified areas on the technical requirements for harmonization agreed upon among Member CountriesSTRATEGIESEXPECTED OUTPUTSTemplate forexchange ofinformationdeveloped andagreed upon.Technicalrequirements(includingterminology anddefinition)of MemberCountriescompiledand analyzedProfile ofTechnicalrequirementsofMemberCountriesdevelopedTerminologyand definitionon TMHSstandardizedin ASEANTechnicalRequirementsand guidelinesof internationaland otherregionalorganizationcompiled,compared andanalyzedTechnicalrequirementsof selectedother countries compiled,comparedand analyzedAppropriate model for ASEAN recommendedSpecific Areas forHarmonizationidentifiedand agreed upon
34Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Why need to set up the FHHTraditional Chinese medicine has been commonly used andtraded with similar theory system among these countries.However, the quality standards and technical requirements inthese countries vary.There is a need for cooperation in harmonization of standardsfor traditional Chinese medicines.Seven founding member parties:1. Australia China3. Japan Republic of Korea5. Singapore Viet Nam7. Hong Kong (SAR China)
35Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) Nature of FHHThe 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.
36Western 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.
37Secretariat (Provisional) Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)Secretariat (Provisional)Hong KongStanding CommitteeSub-committee INomenclature & StandardizationSub-committee IIQuality Assurance & InformationNomenclatureEWGGood Agricultural PracticeEWGInformation on General testEWGGood Manufacturing PracticeEWGValidated Analytical MethodEWGAdverse Drug Reaction, Sub-committee IIITesting method in MonographEWGChemical Reference Standards and Reference of Medicinal Plant MaterialsEWG
382. European Commission (executive body) 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
39Committee on Herbal Medicinal Products Austria France Lithuania SloveniaEstonia Germany Luxembourg SpainBelgium Greece Malta SwedenCyprus Hungary Netherlands United KingdomCzech Rep. Ireland PolandDenmark Italy PortugalFinland Latvia Slovak RepublicEEA Members:Norway, IcelandObserver: EDQM/Europ. Pharm.Romania; Bulgaria
40Herbal Medicinal Products in the EU Access to the market Marketing Authorization1. Full documentation with new tests and trialsmandatory for:- any herbal medicinal product never marketed in the EU - therapeutic innovations - new indication / therapeutic area for “old” products2. Full bibliographic documentation (well-established use)Registration3. Simplified dossier for traditional products
41Annex 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 accountthe time over which a substance has been usedquantitative aspects of the use of the substancethe degree of scientific interest in the use of the substance (reflected in the published scientific literature)the coherence of scientific assessmentsdifferent 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.
42The new simplified registration procedure Registration of traditional herbal medicinal products applicable to traditional herbal medicinal productsArticle 16c 1 (c)> 30 years of medicinal use within the EU or> 15 years in and > 15 years outside the EUDeviations may be decided by the Herbal Committee if requested by a Member State
43Third 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.
44ProjectDrawing 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).
45PAHO/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 medicines42nd PAHO/WHO Directing Council: September 2000Resolution supporting PANDRH
46PANDRH Structure and Operating System Pan American ConferenceRegulatorsAndean AreaCARICOMMERCOSURSICANAFTAINDUSTRYSecretariatSteering CommitteeConsumersAcademiaProfessional AssWGWGWGWGWGWG
47Organization of PADRH NRA Members Alternate NA: Mexico USA CA*: Costa Rica PanamaCR*: Trinidad &Tobago BarbadosME*: Argentina ChileAA: Colombia BoliviaPharmaceutical IndustryOne rep from FIFARMAOne rep from ALIFAR
48Mission 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.
49Objectives of ANDRAH Working Group of Herbal Medicines To promote and strengthen the exchange of information about MPTo 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.
50WHO 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)
51International 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.
52International 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 inOctober 2006, Beijing, China
53ConclusionStatus 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 aspectWHO will provide support to the international and regional regulatory cooperation for herbal medicines
54Thanksfor all of your support and cooperation in the past and looking forward in the futureTraditional MedicineDepartment of Technical Cooperation for Essential Drugs and Traditional MedicineWebsites: http//www.who.int