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

Author : ella | Published Date : 2022-08-23

ICH Topic Q 5 B Quality of Biotechnological Products Analysis of the Expression Construct in Cell Lines Used for Production of rDNA Derived Protein Products NOTE

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

ICH Topic Q 5 B Quality of Biotechnological Products Analysis of the Expression Construct in Cell Lines Used for Production of rDNA Derived Protein Products NOTE FOR GUIDANCE ON QUALITY OF BIOTE. europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the s ource is acknowledged 26 May 2014 EMA1615302014 Inspections and Human Medicines Pharmacovigilance Division DRAFT etailed uid regarding the onit 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 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 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 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 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 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories NOTE FOR GUIDANCE ON DEFINITIONS FOR GENOMIC BIOMARKERS, PHARMACOGENOMICS, PHAR 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 (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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