Clinical trials: Proposal for a regulation planned for July
By Sophie Petitjean | Tuesday 15 May 2012
The European Commission is currently putting the finishing touches to its proposal for the revision of Directive 2001/20/EC on clinical trials, which should take the form of a regulation. The announcement was made, on 15 May, by Stefano Soro of the Commission’s DG Health and Consumers at a conference on intensive care.
Soro was reluctant to elaborate, but he did reveal an outline of the new proposal, which is set to reduce bureaucracy while safeguarding participants’ safety. The directive on clinical trials sets the conditions for clinical trials of medicine for human consumption. Yet, since its implementation on 1 May 2004, requests to conduct clinical trials have reduced in the EU27 (25% decrease between 2007 and 2011).
The new proposal is set to simplify, harmonise and rationalise procedures. In order to facilitate the authorisation process to carry out a clinical trial, it should propose the establishment of a single European portal to centralise applications and redirect them to the competent authorities. The new proposal also aims to accelerate evaluation procedures by making them more flexible and encouraging coordination during multinational trials. The proposal will then try to adapt them to risk criteria through more detailed and flexible rules depending on the type of trial. Lastly, it will deal with the global aspects of clinical trials while respecting the competence of national courts. The proposal for a regulation is currently on the agenda of the 11 July meeting of the College of Commissioners.