Transcription of Gudeline on new vaccines - European Medicines Agency
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Gudeline on new vaccines - European Medicines Agency
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 8545 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 18 October 2006 EMEA/CHMP/VWP/164653/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE CHMP GUIDELINE ON CLINICAL EVALUATION OF NEW vaccines DRAFT AGREED BY VWP May 2005 ADOPTION BY CHMPFOR RELEASE FOR CONSULTATION 26 May 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) 31 December 2005 AGREED BY VWP September 2006 ADOPTION BY CHMP 19 October 2006 DATE FOR COMING INTO EFFECT 1 February 2007 This guideline replaces the Note for Guidance on Clinical Evaluation of New vaccines (CPMP/EWP/463/97) KEYWORDS vaccines , humoral immune response, cellular immune response, vaccination schedule, immunogeicity studies, protective efficacy, effectiveness, s
may find it particularly useful to obtain scientific advice from EU Competent Authorities regarding any unusual scenarios of vaccine development. This guideline should be read in conjunction with all relevant current and future CHMP and ICH guidelines and WHO regulations pertaining to vaccines for pre- and post-exposure prophylaxis against
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