According to the European Commission, the main aim of the revised proposal is to simplify the rules for conducting clinical trials in Europe, while maintaining the highest standards of patient safety.

Once adopted, the proposed Regulation will replace the 2001 ’Clinical Trials Directive’. The objective is to ensure that Clinical Trials rules are identical throughout the EU.

The European Commission proposes:

- An authorisation procedure which should allow a faster assessment of the application by all Member States

- Simplified reporting procedures to avoid having to submit the same information to various Member States

- More transparency on whether recruitment for participating in a clinical trial is still ongoing, and on the results of the clinical trial.

- Possibility for the European Commission to check enforcement of the rules at Member State level.

What next?

The draft Regulation is yet to be agreed by the European Parliament and the Council. Debates should start in the European Parliament in the autumn. The Regulation is expected to come into force by 2016.

EPHA will work with the Pharmaceutical Policy Working Group to assess the draft proposal, based on the EPHA position on clinical trials.

For more information

- European Commission FAQ

- Impact Assessment summary


What difference is there between a Directive and a Regulation?

Both are binding on Member States. A Directive can be adapted to the national or regional context , both in the forms and methods needed to meet the objectives of the Directive. A Regulation is binding in its entirely and is directly applicable to Member States.

Last modified on August 31 2012.