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EMA narrowly defines 'commercially confidential information' amid industry concern

This article was originally published in Scrip

Executive Summary

The European Medicines Agency has finalised its much-awaited guideline on what constitutes "commercially confidential information" and "protected personal data" in a drug marketing authorisation application. Despite reservations by the pharmaceutical industry, non-clinical (ie preclinical) data has not been categorised as commercially confidential, which means it can be made available to the public.




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