Company News
August
2008
ICH Q11 is on the way
- 07/08/08
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.
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