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Focus on Regulation

Tag Archives: Policy 0070

Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power to clinical data submitted before 1 January 2015

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced