EMA Asks for Comments on Applying New EU Regulation to Clinical Trial Database

Jan. 21, 2015, 9:35 PM UTC

The European Medicines Agency (EMA) Jan. 21 asked for comments on its draft document on how the European Clinical Trial Regulation’s transparency rules will be applied in the new clinical trial database.

The document under review sets out proposals for applying the transparency rules that are designed to balance the right of patients and the public to access extensive and timely information on clinical trials with developers’ and researchers’ need to benefit from their investments of money, time and know-how, the EMA said.

Ensuring Transparency, Safety.

The regulation (EU No. 536/2014) requires that the EMA develop and maintain the clinical ...

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