Technical papers - August 2008 ICH Q11 is on the way On 11 April 2008, the International Conference on Harmonisation (ICH) published a concept paper with the title "Q11: Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities)". In ICH's standardised harmonisation process, drawing up a concept paper is the first of five steps on the way to the finalisation of a guideline and its acceptance by the three big industrial regions Europe, USA and Japan. The concept paper contains a proposal for a new guideline and explains why it is necessary. Download paper ICH Q11 is on the way.pdf

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