EU-wide consensus on confidential commercial data in drug marketing applications
This article was originally published in SRA
The European Medicines Agency has finalised a much-awaited guideline on what constitutes "commercially confidential information" and "personal data" in a drug marketing authorisation application1-3. Despite reservations by the pharmaceutical industry, non-clinical data (ie pre-clinical information) has not been categorised as commercially confidential, which means it can be made available to the public4.
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