PDF-European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4

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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

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European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4: Transcript

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. 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 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 United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website www.ema.europa.eu (CHMP) REFLECTION PAPER DRAFT AGREED BY BIOSIMILAR MEDICINAL PRODUCTS WORKING PARTY (BMWP) October 2007 KEYWORDS Interferon alfa, recombinant, similar biological medicinal products, comparability, (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 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 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 NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (CPMP/ICH/2736/99) SION TO CPMP November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COM 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 (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 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) 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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