Combined studies under the new EU clinical trial regulation


Bruno Speder, Head Clinical and Regulatory Affairs & Consultancy at SGS, discusses the benefits and drawbacks of the new EU Clinical Trial Regulation 532/2014

The key aims of the new EU Clinical Trial Regulation 536/2014, which is currently planned for implementation in mid-2019, are to boost clinical research in the European Union (EU).

Its major impact will be a new authorisation process which will involve a single submission via the EMA portal, with a two-step approval procedure: the first step assessing the scientific portion; and the second assessing the local requirements of the application file.

The Regulation has mainly been developed to improve the competitiveness of the EU in late phase clinical research, however early phase clinical research (phase I/IIa) has several specificities which are not covered by the new Regulation 536/2014, potentially introducing additional challenges.

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