PDF-Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union
Author : tatyana-admore | Published Date : 2015-01-15
europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the source is acknowledged 21 March 2014 EMA CHMPCVMPQWP4410712011
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Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union: Transcript
europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the source is acknowledged 21 March 2014 EMA CHMPCVMPQWP4410712011 Rev2 Committee for Medicinal Products for Human Use CHMP Committee for Medicinal P. europaeu Website wwwemaeuropaeu European Medicines Agency 2013 Reproducti on is authorised provided the source is acknowledged 1 February 201 EMACATCPWP6866372011 Committee for Advanced T herapies CAT Guideline on the ri sk based approach according 4420 74 18 84 00 Fax 4420 74 18 86 13 Email mailemeaeuropaeu httpwwwemeaeuropaeu European Medicines Agency 2009 Reproduction is authorised provided the source is acknowledged London 19 February 2009 Doc Ref CHMPEWP24095 Rev 1 COMMITTEE FOR MEDICINA 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 europaeu Website wwwemaeuropaeu 19 March 2014 EMA4308922013 Press Office Press release European Medicines Agency launches adaptive licensing pilot project mproving timely access for patient to new medicines p ilot explore adaptive licensing approa c 4420 74 18 84 00 Fax 4420 74 18 84 09 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2008 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 11 December 2007 CPMP 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 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 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 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 12 Evaluation of New An ICH PRINCIPLES DOCUMENT FOR CLINICAL EVALUATION OF NEW ANTIHYPERTENSIVE DRUGS TRANSMISSION TO CPMP June 2000 TRANSMISSION TO INTERESTED PARTIES June 2000 This (CHMP) AGREED BY EFFICACY WORKING PARTYNovember 2008 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION18 December 2008 ADOPTION BY CHMP 22 October 2009 DATE FOR COMING INTO EFFECT 1 May 2010 EMEA 200
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