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ICH Topic E 11 Clinical Investigation of Medicinal Products in the Paediatric Population Step 5 NOTE FOR GUIDANCE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PAEDIATRIC POPULATION C. 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 2013 Reproduction is authorised provided the source is acknowledged 22 May 2013 CHMP43704 Rev 1 Committee for Medicinal Products for Human Use CHMP Guideline on Similar Biological Medicinal 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 European Medicines Agency 2013 Reproduction is authorised provided the source is acknowledged 28 June 2013 EMA3857162013 Restrictions on use of codeine for pain relief in ch ildren CMDh endorses PRAC recommendation T 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 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 Canary Wharf London E14 4HB An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 E - mail info@ema.europa.eu Website www.ema.europa.eu 7 Westferry Circus Canary Wharf London E14 4HB United KingdomAn agency of the European Union Telephone+44 (0)20 7418 8400 The sponsor has provided sufficient information to show that immortalised hu Canary Wharf London E14 4HB An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimil e +44 (0)20 7418 8416 E - mail info@ema.europa.eu Wbsite www.ema.europa.eu 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 (CHMP) GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRST-IN- HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY CHMP EXPERT GROUP 6 March 2007 ADOPTION BY ICH Considerations General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors TRANSMISSION TO CHMP November 2006 RELEASED FOR INFORMATION November 2006