Clinical trials are an important step during drug development, leading towards marketing authorisation and thus, market access. According to §40 German Drug Law / §7 GCP ordinance, clinical trials have to be approved by the responsible competent authority (CA). Recently, both German CAs (the...
Read moreIt has been over a year since the EMA implemented Policy 0070 on the Publication of Clinical Trial Data; the EMA have published a guidance document and a report of the first year since it was launched (Oct 2016-Oct 2017). Under Policy 70, clinical data has now been published for over 50 products,...
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