EU PHARMACOS ADVISED ON MANAGING MUTAGENIC IMPURITIES
October 1st, 2014
GUIDANCE has been released to European Union (EU) pharma companies to help them assess and control the emergence of mutagenic impurities in medicines that could help cause cancer.This advice was original developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which also advises regulators in Japan and the USA, and has been assessed and released in the EU by the European Medicines Agency (EMA). It advises on clinical development and marketing authorisation procedures for new ...
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