EMA RELEASES NEW GUIDELINE ON STABILITY TESTING
April 12th, 2014
GUIDANCE on stability testing during applications for variations to an existing marketing authorisation has been released by the European Medicines Agency (EMA). It states what stability data should generally be required, while allowing for “sufficient flexibility to encompass the variety of different practical situations” regarding the science and material under evaluation.For instance, the new guidance says if the quality characteristics of an active substance are changed so that stability may be compromised, comparative stability data is recommended. For ...
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