Agreement on clinical trials - major step towards innovative and competitive Europe

20 December 2013, Last updated at, 13:27 EEST
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author: AFP/Scanpix

On Friday in the Committee of Permanent Representatives (COREPER I) the Member States endorsed the agreement reached by the Lithuanian EU Council Presidency and the European Parliament on the Proposal for a Regulation on Clinical trials on medicinal products for human use (and repealing Directive 2001/20/EC).

The aim of this legislative act is to facilitate and speed up the authorisation procedure for clinical trials and as a result to increase the number of clinical trials in the European Union. In response to requests from scientists and in order to meet patients' needs, the particular goal of the regulation is to stimulate clinical trials conducted by non-commercial sponsors, e.g. hospitals and university clinics.

According to the Minister of Health of Lithuania Vytenis Povilas Andriukaitis, adoption of this Regulation is a major step towards innovative and more competitive Europe with a view to the health sector, whereas the ambition of a high level of protection for patients is a key thread.

“This legislative act paves way towards achieving an internal market as regards clinical trials and medicinal products for human use, taking as a base a high level of protection of health. It also sets high standards of quality and safety for medicinal products to meet common safety concerns. What is very important - both objectives are being pursued simultaneously,” said Minister Andriukaitis.

This Regulation harmonises the rules for the conduct of clinical trials in the EU, and also the acceptability throughout the Union of data generated in a clinical trial. It sets high standards of the quality and safety of medicinal products by ensuring that data generated in clinical trials is reliable and robust. Moreover, it sets high standards of subjects' safety in clinical trials in the EU.

“We believe that timelines for authorisation of clinical trials will be competetive and the harmonised authorisation procedures in all EU countries will stimulate the conduct of clinical trials in the EU,” said the Minister.

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