On May 27, 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU). It will replace the existing EU Clinical Trials Directive and streamline the authorization process. The legal form of a Regulation ensures that EU Member States, in authorizing and supervising the conduct of a clinical trial, do so on the basis of identical rules. Barring IT issues, it will apply starting from May 28, 2016.
The key provisions include:
- Applicants will submit a single application for the authorization of a clinical trial via a single EU portal. Applications will receive a single assessment outcome, regardless of the number of EU Member States concerned.
- The European Commission will have the possibility to conduct controls in EU countries and third countries to make sure rules are being properly supervised and enforced.
- Certain clinical trials determined to be “low-intervention,” such as those comparing already authorized medicines, will be subjected to lighter regulatory requirements.
- Clinical trials conducted outside the EU but referred to in a clinical trial application within the EU must comply with regulatory requirements at least equivalent to those in the EU, including rules on transparency.
- Member States will have the possibility to stop any clinical trial which they consider could endanger the heath of the participants.