New Clinical Trials Regulation published
Recommendation
9/10 May 2023
From QbD to Process Validation
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The new Clinical Trials Regulation with the official title "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC" has been published in the Official Journal of the EU.
Besides the goal to simplify clinical trial approvals, the Regulation aims to foster transparency on the conduct of trials in the European Economic Area (EEA). This will be achieved now by providing the legal basis for the publication of clinical trial results. The respective IT-tools and platforms will be implemented by the European Medicines Agency (EMA) to "support sponsors and experts in the Member States in carrying out their roles in relation to the authorisation of trials, their supervision, safety reporting and compliance activities, as well as to enable public access to information on clinical trials".
Source: EMA press release
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