Clinical Trials Regulation adopted in Parliament

The new EU Clinical Trials Regulation has recently passed the EU Parliament. The objective of the new document was to simplify the authorisation procedures for multinational clinical trials. One of the most important aspects is the obligation to publish all results of a clinical trial - both for experts (with explicit details) and for all stakeholders (as a summary). These data should be made available on a web portal of the EU Medicines Agency - EMA. Moreover, children and adolescents' rights in clinical trials should now be harmonised in the entire EU.

The new regulation should come into force by the mid of 2016 - provided that the web portal in question is in place, in which all trial applications and publications will also be entered. An application submitted there (including the list of the EU countries concerned by the trial) will replace all the separate national applications required today for a multination study. This should help reduce bureaucracy which is very good news for associations like for example the vfa.

According to Birgit Fischer, Director General of the German Association of Research-based Pharmaceutical Companies (vfa), the new regulation reduces bureaucracy for trial applications in Europe while ensuring medical and ethical standards for the participants - which is greatly welcome! Besides, the regulation reinforces the cooperation of national ethics committees within the authorisation procedures.

Sources:

• Press release of the vfa
• Proposal for a regulation A7-0208/2013