Apr 3, 2014

EU Clinical Trials legislation Update

A significant step towards the new Clinical Trials legislation was taken yesterday in the European decision-making process as it was formerly adopted by the Plenary of the European Parliament on 2 April 2014. Ms. Glenis Willmott MEP, the Parliament rapporteur for this dossier, highlighted that this new legislation would allow for patients with rare diseases to receive new treatments faster. In that sense, the newly adopted text ensures special provisions for the evaluation of medicines intended for rare diseases and shorten the timelines for the assessment of the trial. One of the more discussed provisions in the future legislation was the transparency of the clinical trials data and its degree of availability to researchers and the general public. In the end, the text includes strong wording on transparency of clinical trials data establishing a publicly available data base which is to contain all clinical trials data for clinical trials in the European Union. Additional measures such as the submission of a single dossier for a trial due to take place in several EU countries is also considered to favour the development of clinical trials.

The new legislation should be finally adopted by the Council of Ministers in June 2014.

The text adopted yesterday by the European Parliament can be found here and an executive summary here.

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