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GLP Status of non-clinical Studies in Clincal Trials

Date 2014.01.17

In the light of recent events, the BfArM would like to inform all sponsors that all non-clinical safety studies should be conducted in conformance with the principles of OECD-GLP and in a country that is part of the OECD Mutual Acceptance of Data process. Sponsors are requested to confirm this information in the application dossiers, preferably in the cover letter.

Date 2014.01.17