GLP Status of non-clinical Studies in Clincal Trials
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.