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

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. 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 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 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 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 (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 ICH Topic E 10 Choice of Control Group in Clinical Trials NOTE FOR GUIDANCE ON CHOICE OF CONTROL GROUP IN CLINICAL TRIALS TRANSMISSION TO CPMP June 1999 LTATION June 1999 DEADLINE FOR COMMENTS Decem 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 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) GUIDELINE ON FOLLOW-UP OF PATIENTS ADMINISTERED WITH GENE THERAPY MEDICINAL PRODUCTS AGREED BY GENE THERAPY WP April 2008 AGREED BY PHARMACOVIGILANCE WP March 2008 ADOPTION BY CHMP FOR REL