European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use

DRAFT AGREED BY BIOLOGICS WORKING PARTY 18 April 2007 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 24 May 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) 30 November 2007 AGREED BY BIOLOGICS WORKING PARTY 12 November 2008 ADOPTION BY CHMP 18 December 2008 DATE FOR COMING INTO EFFECT 1 July 2009 This guideline replaces the guideline on “Production and quality control of monoclonal antibodies” (3AB4A) This guideline replaces the quality requirements for monoclonal antibodies set forth in the guideline on “Radiopharmaceuticals based on monoclonal antibodies” (3AQ21A)