AFRICA HERBAL ANTIMALARIAL MEETINGORGANISED BY THE WORLD AGROFORESTRY CENTRE.ppt
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1、AFRICA HERBAL ANTIMALARIAL MEETING ORGANISED BY THE WORLD AGROFORESTRY CENTRE (ICRAF) AND THE ASSOCIATION FOR THE PROMOTION OF TRADITIONAL MEDICINE (PROMETRA),MARCH, 20th TO 22nd 2006 ICRAF HOUSE NAIROBI, KENYA,NEW EUROPEAN LEGISLATION FOR HERBAL MEDICINAL PRODUCTS (HMPs) - NEW OPPORTUNITIES FOR AFR
2、ICAN PHARMACEUTICAL INDUSTRIES?, CHAIRMAN OF THE GROUP OF EXPERTS 13A OF THE EUROPEAN PHARMACOPOEIA (EP) MEMBER OF THE COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) OF THE EUROPEAN MEDICINES AGENCY (EMEA),CONTENTS 1. INTRODUCTION 2. LEGAL FRAMEWORK FOR HMPs IN THE EU 2.1. MARKETING AUTHORISATION (MA
3、) PROCEDURES 2.2. MA OF WELL-ESTABLISHED HMPs 2.3. REGISTRATION OF TRADITIONAL HMPs 3. EUROPEAN PHARMACOPOEIA MONOGRAPHS OF HERBAL DRUGS AND HERBAL PREPARATIONS 4. NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA 5. MA OR REGISTRATION OF ANTIMALARIALS FROM ARTEMISIA ANNUA
4、 6. CONCLUSION,LEGAL STATUS OF HERBAL PRODUCTS WORLDWIDE,DIETARY SUPPLEMENTS,NUTRACEUTICALS,HERBAL PRODUCTS,FUNCTIONAL FOODS,HERBAL MEDICINAL PRODUCTS,DESIGNER FOODS,FITNESS FOODS,FOODACEUTICALS,LONGEVITY FOODS,MEDICINAL FOODS,NUTRITIONAL FOODS,.,THERAPEUTIC FOODS,HERBAL MEDICINAL PRODUCTS PRESCRIBE
5、D BY MEDICAL DOCTORS PRESCRIPTION SHARES BY COUNTRY IN %,CURRENT LEGAL FRAMEWORK FOR HMPs IN THE EU,DIRECTIVE 2001/83/EC, AS AMENDED (12.06.2003), ART. 1 : DEFINITION OF MEDICINAL PRODUCTS (a) ANY SUBSTANCE OR COMBINATION OF SUBSTANCES PRESENTED AS HAVING PROPERTIES FOR TREATING OR PREVENTING DISEAS
6、E IN HUMAN BEINGS (b) ANY SUBSTANCE OR COMBINATION OF SUBSTANCES WHICH MAY BE USED IN OR ADMINISTERED TO HUMAN BEINGS WITH A VIEW TO MAKING A MEDICAL DIAGNOSIS OR TO RESTORING, CORRECTING OR MODIFYING PHYSIOLOGICAL FUNCTIONS BY EXERTING A PHARMACOLOGICAL, IMMUNOLOGICAL OR METABOLIC ACTION, WHEREBY “
7、SUBSTANCE . ANY MATTER E.G. VEGETABLE: PLANTS, PARTS OF PLANTS, VEGETABLE SECRETIONS, EXTRACTS ” ESTABLISHES THAT PROOF OF QUALITY, SAFETY AND EFFICACY IS A PRECONDITION FOR DELIVERING A MARKETING AUTHORIZATION FOR A MEDICINAL PRODUCT.,CURRENT LEGAL FRAMEWORK FOR HERBAL MEDICINAL PRODUCTS MA PROCEDU
8、RES,National,Mutual recognition,Centralised (?),Marketing authorisation : “A medicinal product may only be placed on the market in the European Union when a marketing authorisation has been issued by the competent authority of a Member State for its own territory (national authorisation) or when an
9、authorisation has been granted in accordance with Regulation (EEC) No. 2309/93 for the entire Community (a Community authorisation).”,FRIAS, 2004,HERBAL MEDICINAL PRODUCTS (HMPs) IN THE EU, REGULATORY GUIDANCE ON SOLID GROUNDS,DIRECTIVE 2001/83/EC AS AMENDED BY DIRECTIVE 2004/24.EC AND DIRECTIVE 200
10、4/27/EC OF 31.03.2004, HMPs IN THE EU : ACCESS TO THE MARKET MARKETING AUTHORIZATION (MA) 1. FULL DOCUMENTATION WITH NEW TESTS AND TRIALS 2. FULL BIBLIOGRAPHIC DOCUMENTATION (WELL-ESTABLISHED USE) 3. MIXED APPLICATIONS REGISTRATION 4. SIMPLIFIED DOSSIER FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS,REGU
11、LATION No 726/2004 (EC) OF 31.03.2004 TITLE IV, THE EUROPEAN MEDICINES AGENCY (EMEA) RESPONSIBILITIES AND ADMINISTRATIVE STRUCTURE ARTICLE 56 1. (d) HMPs,CURRENT LEGAL FRAMEWORK FOR HMPs IN THE EU,* DIRECTIVE 2003/63/EC (UPDATED ANNEX I TO THE DIR. 2001/83/EC) DOSSIER REQUIREMENTS SPECIFIC REQUIREME
12、NTS FOR THE DOCUMENTATION AND EXPERT REPORTS ON QUALITY, SAFETY AND EFFICACY SPECIFIC PART ON APPLICATIONS FOR HMPs SPECIFIC PART ON BIBLIOGRAPHIC APPLICATIONS, PRESENTATION AND FORMAT OF AN APPLICATION - OLD NOTICE TO APLLICANTS (NTA) 1998 EDITION (PARTS I- IV) - NEW COMMON TECHNICAL DOCUMENT (CTD)
13、 2001 EDITION (MODULES 1 - 5) TRANSITION FOR “OLD” HMPs APPLICATIONS UNTIL 30.04. 2005 MANDATORY FOR “NEW” HMPs APPLICATIONS SINCE 01.07.2003,LEGAL BASIS FOR SUBMISSION OF HMPs IN THE EU,* COMPLETE AND INDEPENDENT APPLICATION / STAND ALONE APPLICATION ART. 8. 3 (i) OF DIR. 2001/83/EC “COMPLETE DOSSI
14、ER APPLICATION” BASED ON THE MANUFACTURERS OWN QUALITY, PRECLINICAL AND CLINICAL RESEARCH DATA,* BIBLIOGRAPHIC APPLICATION ART. 10.1 (a) (ii) OF DIR. 2001/83/EC 1. IN DEROGATION OF ART. 8.3.(i), AND (a) THE APPLICANT SHALL NOT BE REQUIRED TO PROVIDE THE RESULTS OF PHARMACOLOGICAL AND TOXICOLOGICAL T
15、ESTS OR THE RESULTS OF CLINICAL TRIALS IF HE CAN DEMONSTRATE : ii) . BY DETAILED REFERENCE TO PUBLISHED SCIENTIFIC LITERATURE THAT THE CONSTITUENT OR CONSTITUENTS OF THE PROPRIETARY MEDICINAL PRODUCT HAVE A WELL ESTABLISHED MEDICINAL USE, WITH RECOGNIZED EFFICACY AND AN ACCEPTABLE LEVEL OF SAFETY, C
16、AN BE A “MIXED DOSSIER” APPLICATION INCLUDING BOTH EXISTING BIBLIOGRAPHIC EVIDENCE SUPPLEMENTED WITH THE APPLICANTS OWN RESEARCH DATA.,* ALTHOUGH THE FULL AND BIBLIOGRAPHIC LEGAL BASES HAVE BEEN TRANSPOSED INTO THE NATIONAL LEGISLATION, THERE ARE MAJOR DISCREPANCIES BETWEEN THE MS IN THE CLASSIFICAT
17、ION AS WELL AS IN THE DOSSIER REQUIREMENTS FOR OBTAINING A MARKETING AUTHORIZATION.,“ WELL-ESTABLISHED USE” DEMONSTRATION (WEU) (1),CTD 3.2 (a) : THE TIME OVER WHICH A SUBSTANCE HAS BEEN USED, NOT LESS THAN 10 YEARS FROM FIRST AND SYSTEMATIC USE AS A MEDICINAL PRODUCT; QUANTITATIVE ASPECTS OF THE US
18、E OF THE SUBSTANCE; THE DEGREE OF SCIENTIFIC INTEREST IN THE USE OF THE SUBSTANCE, AND THE COHERENCE OF SCIENTIFIC ASSESSMENTS.,CTD 3.2 (b) : BIBLIOGRAPHY “SHOULD COVER ALL ASPECTS OF THE SAFETY AND/OR EFFICACY ASSESSMENT AND MUST INCLUDE OR REFER TO A REVIEW OF THE RELEVANT LITERATURE, TAKING INTO
19、ACCOUNT PRE-AND POST-MARKETING STUDIES AND PUBLISHED SCIENTIFIC LITERATURE CONCERNING EXPERIENCE IN THE FORM OF EPIDEMIOLOGICAL STUDIES AND IN PARTICULAR OF COMPARATIVE EPIDEMIOLOGICAL STUDIES”.,ANNEX 1 TO CD 2001/83 EC AMENDED BY CD 2003/63 (25.06.2003),“ WELL-ESTABLISHED USE” DEMONSTRATION (WEU) (
20、2),CTD 3.2 (d) : NON-CLINICAL AND /OR CLINICAL OVERVIEWS MUST EXPLAIN RELEVANCE OF ANY DATA SUBMITTED WHICH CONCERN A PRODUCT DIFFERENT FROM THE PRODUCT INTENDED FROM MARKETING. CTD 3.2 (e) : POST-MARKETING EXPERIENCE WITH OTHER PRODUCTS CONTAINING THE SAME CONSTITUENTS IS OF PARTICULAR IMPORTANCE A
21、ND APPLICANTS SHOULD PUT A SPECIAL EMPHASIS ON THIS ISSUE.,CTD 3.2 (c) : MISSING INFORMATION : JUSTIFICATION MUST BE GIVEN,ANNEX 1 TO CD 2001/83 EC AMENDED BY CD 2003/63 (25.06.2003),DIRECTIVE 2004 / 24 / EC ON TRADITIONAL HERBAL MEDICINAL PRODUCTS (THMPs) (2),* NEW LEGAL BASIS AND PROCEDURE SIMPLIF
22、IED REGISTRATION OF TRADITIONAL HERBAL MEDICINAL PRODUCTS (THMPs) UNDER ARTICLE 16A DOES NOT APPLY IN CASE THE “TRADITIONAL” HERBAL PRODUCT FULFILS THE CRITERIA FOR A FULL MARKETING AUTHORISATION APPLICATION TO THE COMPETENT AUTHORITY OF THE MEMBER STATE (MS) TIMEFRAME FOR IMPLEMENTATION - 210 DAYS
23、REVIEW - MEMBER STATES : MAX. 18 MONTHS - EMEA : MAX. 18 MONTHS (STARTING ON 22.09.2004) - THMPs ALREADY ON THE MARKET IN THE MS : COMPLIANCE WITHIN 7 YEARS (04.2011).,DIRECTIVE 2004 / 24 / EC ON TRADITIONAL HERBAL MEDICINAL PRODUCTS (THMPs) (3),* SCOPE INDICATION (S) EXCLUSIVELY APPROPRIATE TO THMP
24、s AND DESIGNED FOR USE WITHOUT SUPERVISION OF A MEDICAL PRACTITIONER FOR DIAGNOSIS, PRESCRIPTION OR MONITORING OF TREATMENT SPECIFIED STRENGTH AND POSOLOGY ONLY ORAL OR EXTERNAL USE AND INHALATION PERIOD OF TRADITIONAL USE : 30 YEARS (15 YEARS IN AND 15 YEARS OUTSIDE THE EU), UNLESS OTHERWISE DECIDE
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