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Chinese Medicines Products and the European Union Regulatory Framework an Update

Chinese Medicines Products and the European Union Regulatory Framework an Update Prof. Dr. Werner Knöss Chairperson HMPC, EMA Head of Division 4, BfArM Werner Knöss Hongkong 10 September 2015 Page 1 Disclaimer
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Chinese Medicines Products and the European Union Regulatory Framework an Update Prof. Dr. Werner Knöss Chairperson HMPC, EMA Head of Division 4, BfArM Werner Knöss Hongkong 10 September 2015 Page 1 Disclaimer With reference to the publication policy of the European Medicines Agency (EMA) I do not speak on behalf of the Committee on Herbal Medicinal Products (HMPC) or the EMA. The views expressed here may not be understood or quoted as being made on behalf of the HMPC/EMA or reflecting the position of the HMPC/EMA. Werner Knöss Hongkong 10 September 2015 Page 2 Contents 1. Introduction 2. Legislation on Traditional and Herbal Medicinal Products in the European Union 3. HMPC Monographs 4. Perspectives for traditional medicines of non European origin 5. Conclusions Werner Knöss Hongkong 10 September 2015 Page 3 Traditional medicines all over the world Werner Knöss Hongkong 10 September 2015 Page 4 European Union Political union of 28 Member States about 500 Mio inhabitants 24 official languages Werner Knöss Hongkong 10 September 2015 Page 5 Pharmaceutical Legislation in the EU CD 2001/83 ( Basic regulation on medicinal products) amended by CD 2003/63 (Annex I, CTD criteria) CD 2004/24 (Traditional herbal medicinal products) Werner Knöss Hongkong 10 September 2015 Page 6 Pharmaceutical Legislation in the EU Definitions Medicinal product Herbal medicinal product Traditional herbal medicinal product (longstanding tradition, plausibility) Herbal substance (Eur. Ph. Herbal drug ) Herbal preparation (Eur. Ph. Herbal drug preparation ) Werner Knöss Hongkong 10 September 2015 Page 7 Key Institutions European Commission European Parliament Regulatory framework, law Directives, Regulations National authorities Assessment Marketing authorisation DCP, MRP, national European Pharmacopeia Quality standards General Herbal drugs/preparations EMA Coordination Guidance Centralised procedure Werner Knöss Hongkong 10 September 2015 Page 8 Tasks EMA HMPC monographs Safety + Efficacy Standards European Pharmacopeia National authorities or EMA (centralised) Product applications Assessment Licensing Eur. Ph. monographs Quality Werner Knöss Hongkong 10 September 2015 Page 9 Access to the Market Options and Concepts Marketing authorisation full application (e. g. new medicinal products) well established use Registration traditional use Werner Knöss Hongkong 10 September 2015 Page 10 Specific Concepts Well established use More than 10 years accepted medicinal use in the EU based on a marketing authorization Quantitative substantiation of use of the substance Degree of scientific interest in the use of the substance Coherence of bibliographic scientific data, scientific assessments and published scientific literature HMPC monographs: at least one controlled clinical trial of good quality Werner Knöss Hongkong 10 September 2015 Page 11 Specific Concepts Traditional Use 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 Medicinal Products Committee (HMPC, EMA) if requested by a Member State Werner Knöss Hongkong 10 September 2015 Page 12 Specific Concepts Traditional Use Indication(s) appropriate minor diseases Without the supervision of a medical practitioner for diagnosis, prescription or monitoring of treatment Only oral, external and inhalation Sufficient data on traditional use Pharmacological effects / efficacy plausible on the basis of long standing use and experience Werner Knöss Hongkong 10 September 2015 Page 13 Marketing Authorisation Registration Pharmacovigilance Consumer information; labeling; advertising Efficacy new trials bibliographic Safety new tests bibliographic traditional use expert report bibliographic new tests Quality Control Good Manufacturing Practices Good Agricultural and Collection Practices new well established traditional Werner Knöss Hongkong 10 September 2015 Page 14 Contents 1. Introduction 2. Legislation on Traditional and Herbal Medicinal Products in the European Union 3. HMPC Monographs 4. Perspectives for traditional medicines of non European origin 5. Conclusions Werner Knöss Hongkong 10 September 2015 Page 15 HMPC and Development of European Union Monographs HMPC and guests at the presidency meeting 2015 Werner Knöss Hongkong 10 September 2015 Page 16 European Medicines Agency EMA Central European Authority with specified tasks Committees and Working Parties Coordination of National Competent Authorities Documents ( Werner Knöss Hongkong 10 September 2015 Page 17 Committees at EMA CHMP Committee on Medicinal Products for Human Use COMP Committee on Orphan Medicinal Products PDCO Paediatric Committee HMPC Committee on Herbal Medicinal Products CAT Committee on Advanced Therapies CVMP Committee on Medicinal Products for Veterinary Use COMPOSITION: 1 member per Member State 1 member each from Norway and Iceland Up to 5 co opted Members Alternate Members, Observers (e. g. EDQM) PRAC Pharmacovigilance Rsik Assessment Committee Werner Knöss Hongkong 10 September 2015 Page 18 EU Legal Framework and Different Traditions Werner Knöss Hongkong 10 September 2015 Page 19 HMPC Elaboration of Harmonised Standards European Union Monographs on safety and efficacy Guidance documents Werner Knöss Hongkong 10 September 2015 Page 20 Documents developed by the HMPC HMPC Monographs on efficacy and safety recommendation to Member States List Entries published by EC, binding to Member States Public Statements specific information (e. g. no release of a monograph, safety of specific constituents) Revisions every 5 years, sustainability of the system Guidelines recommendations to national competent authorities and applicants, consensus on harmonized assessment Reflection Paper, Questions & Answers regulatory perspectives on selected topics Werner Knöss Hongkong 10 September 2015 Page 21 HMPC Achievements Monographs 140 List Entries 13 Revisions 16 Public Statements 13 Guidance about 30 Werner Knöss Hongkong 10 September 2015 Page 22 Standards made public Agendas Meeting reports Minutes Monographs Assessment reports References Comments Guidelines Werner Knöss Hongkong 10 September 2015 Page 23 Therapeutic Areas of Traditional Herbal Medicinal Products (reference: Werner Knöss Hongkong 10 September 2015 Page 24 Monographs Request for Data Werner Knöss Hongkong 10 September 2015 Page 25 Monographs Options for Input of Data Call for data before start of the work Public consultation after finalisation of a draft monograph Support by interested parties Scientifically based and justified input with supporting documentation is welcome Werner Knöss Hongkong 10 September 2015 Page 26 Contents 1. Introduction 2. Legislation on Traditional and Herbal Medicinal Products in the European Union 3. HMPC Monographs 4. Perspectives for traditional medicines of non European origin 5. Conclusions Werner Knöss Hongkong 10 September 2015 Page 27 Traditional medicine from non European countries in Europe May be available in pharmacies May be available in herbalist shops May be applied in specialized hospitals May be offered via internet May be sold with different classification Need for harmonisation Werner Knöss Hongkong 10 September 2015 Page 28 HMPC Work Program High Regulatory guidance for non European interested parties 2012 Initiate pilot projects for herbal substances with a non European traditional background. Identify central questions or obstacles and provide specific information in conjunction with a training for assessors. High Harmonisation of assessment practice for herbal substances of non European origin Werner Knöss Hongkong 10 September 2015 Page 29 HMPC Activities towards non European traditional medicines 2014 Question & Answers ( non European ) 2013 Pilot Project on Monographs for herbal substances from traditional medicines of non European Origin 2012 HMPC Assessors Training on non European Traditional Medicines 2011 HMPC delegation in Bejing (seminar, meetings with authorities) Werner Knöss Hongkong 10 September 2015 Page 30 Questions & Answers Document Werner Knöss Hongkong 10 September 2015 Page 31 Experiences No sufficient data to support well established use No sufficient data to support tradition of years No sufficient data on posology No sufficient data on safety and plausibility Future task: search for strategies and solutions Werner Knöss Hongkong 10 September 2015 Page 32 From non European countries to Europe Access to the European market for finished medicinal products according to European legislation fulfilling requirements traditional, (well established use), new product Procedures for finished medicinal products national procedure decentralised/ mutual recognition procedure centralised procedure Werner Knöss Hongkong 10 September 2015 Page 33 Examples of Two Successful Applications for Traditional Herbal Medicinal Products Professional strategies include Early scientific advice (national or European level) Ressources Sound data and adequate documentation Successful applications Traditional herbal medicinal products Werner Knöss Hongkong 10 September 2015 Page 34 Conclusions 1. HMPC has developed harmonised European standards for the Member States of the European Union. 2. The European legal framework offers options for (traditional) herbal medicinal products from non European countries. 3. HMPC has followed different approaches to strive for harmonised assessment of (traditional) herbal medicinal products from non European countries. 4. Scientific advise is offered and professional applicationsare welcome. 5. Communication amongst regulators at global level is developing. Werner Knöss Hongkong 10 September 2015 Page 35 Thank you very much for your attention! Contact Federal Institute for Drugs and Medical Devices Division 4 Kurt-Georg-Kiesinger-Allee 3 D Bonn Contact person Werner Knöss Werner Knöss Hongkong 10 September 2015 Page 36
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