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

Author : hadley | Published Date : 2022-08-16

NOTE FOR GUIDANCE ON STABILITY TESTING STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS CPMPICH273699 SION TO CPMP November 1999 RELEASE FOR CONSULTATION November

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European Medicines Agency 7 Westferry Circus Canary Wharf London E1: Transcript

NOTE FOR GUIDANCE ON STABILITY TESTING STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS CPMPICH273699 SION TO CPMP November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COM. 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 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 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 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 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 D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Step 5NOTE FOR GUIDANCE ON QUALI 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 9 Statistical Principles for Clinical Trials Step 5 NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS (CPMP/ICH/363/96) TRANSMISSION TO CPMP February 1997 RELEASE FOR CONS (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 (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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