Lithuanian Presidency to start negotiations on clinical trials regulation

30 October 2013, Last updated at, 16:30 EEST
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author: PantherMedia/Scanpix

The Committee of Permanent Representatives (COREPER I) mandated the Lithuanian Presidency to enter into negotiations with the European Parliament and the Commission with the aim to reach an agreement at first reading on the Proposal for a Regulation on Clinical trials on medicinal products for human use, which aims to facilitate the conduct of clinical trials and thus increase their number in the EU, which could result in better treatment of patients.

“It is important both for European patients and for the European industry that new treatments based on new and existing medicinal products can be tested in a safe way. We believe that the new Regulation will contribute to that end. It is a priority for the Lithuanian EU Council Presidency, and it is in our common interest that the new Regulation is adopted as soon as possible,”said ambassador Arūnas Vinčiūnas, Chair of the Committee.

The aim of the proposed Regulation is to facilitate 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 proposal aims to stimulate clinical trials conducted also by non-commercial sponsors, e.g.  hospitals and university clinics. This proposal was presented in response to the fact that the share of clinical trials performed in the EU out of all clinical trials has decreased over recent years.

The Presidency compromise text was presented to the Committee, found a very broad support and will serve as a starting point for negotiations with the European Parliament. The first informal trilogue will take place on 6 November.


The proposal was presented by the European Commission in July 2012. This new Regulation repeals Directive 2001/20/EC.  

The Committee on the Environment, Public Health and Food Safety of the European Parliament voted on the Proposal on 29 May 2013.

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