EU - New Regulation on clinical trials

EU Regulation 536/2014 on clinical trials on medicinal products for human use replaces the existing EU Directive 2001/20/EC on the same subject. Under the new Regulation, a web-based portal will be created to make it more efficient to approve and process applications for clinical trials that sponsors wish to carry out in an EU member state. In addition, sponsors will be required to publish results of clinical trials on a centralised database that will be available to the public.

Member states will be required to put in place a system that requires that clinical trials conducted in their territory are subject to an insurance guarantee or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk. For example, a member state could make clinical trials a compulsory class of insurance or it could set up a national insurance pool.

However, clinical trials that are “low intervention clinical trials” (as defined) will not be subject to this requirement.

The Regulation automatically entered into force in all EU member states on 16 June 2014. It will not be effective until six months after the new web-based portal and database have become operational, and in any event not earlier than 28 May 2016.

A copy of the Regulations is available here.