PDF-European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E1

Author : conchita-marotz | Published Date : 2016-06-27

CHMP GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRSTIN HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY CHMP EXPERT

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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E1: Transcript

CHMP GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRSTIN HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY CHMP EXPERT GROUP 6 March 2007 ADOPTION BY. europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the s ource is acknowledged 26 May 2014 EMA1615302014 Inspections and Human Medicines Pharmacovigilance Division DRAFT etailed uid regarding the onit europaeu Website wwwemaeuropaeu European Medicines Agenc y 2013 Reproduction is authorised provided the source is acknowledged 03 June May 2013 EMEACHMPBMWP428322005 Rev 1 Committee for Medicinal Products for Human Use CHMP Guideline on similar bio 4420 74 18 84 00 Fax 4420 74 18 85 45 Email mailemeaeuropaeu http wwwem eaeuropaeu EMEA 2007 Reproduction andor distribution of this document is authoris ed for non commercial purposes only provided the EMEA is acknowledged London 19 July 2007 Doc R 2(5) 3. Submission of request The request for a recommendation for classification from the MAH for a centrally authorised product shall be submitted to the EMEA electronically to a dedicated mail (CHMP) REFLECTION PAPER DRAFT AGREED BY BIOSIMILAR MEDICINAL PRODUCTS WORKING PARTY (BMWP) October 2007 KEYWORDS Interferon alfa, recombinant, similar biological medicinal products, comparability, ICH Topic Q 5 A (R1) Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Step 5 NOTE FOR GUIDANCE ON QUALITY O (CHMP) REFLECTION PAPER ON METHODOLOGICAL ISSUES IN CONFIRMATORY CLINICAL TRIALS PLANNED WITH AN ADAPTIVE DESIGN DRAFT AGREED BY THE EFFICACY WORKING PARTY 11 January 2006 ADOPTION BY CHMP FOR REL ICH Topic Q 3 B (R2) Impurities in New Drug Products TRANSMISSION TO INTERESTED PARTIES November 1999 RELEASE FO DEADLINE FOR COMMENTS May 2000 APPROVAL BY CPMP February 2003 DATE FOR COMING INT Comparability of Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS CPMP/ICH/5721/03TRANSMISSION ICH Topic E 1 Population Exposure The Extent of Population Exposure to Assess Clinical Safety Step 5NOTE FOR GUIDANCE ON POPULATION EXPOSURE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY On 19 February 2009, Denmark (DK) presented to the EMEA a request for a CHMP opinion under Article 5(3) of Regulation (EC) No 726/2004 to Currently, medicinal products authorised in the European Union ICH Topic Q 5 B Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products NOTE FOR GUIDANCE ON QUALITY OF BIOTE ICH Topic E 7 Studies in Support of Special Populations: Geriatrics Step 5NOTE FOR GUIDANCE ON STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS (CPMP/ICH/379/95) APPROVAL BY CPMP September 1

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