Clinical trial sponsors in France no longer need to pay the two sets of registration fees introduced by decree in August 2006.
The removal of the fees payable for securing clinical trial approval from the French medicines agency, Afssaps, and the relevant ethics committee (CPP) was part of France’s national budget for 2009, which included a number of measures aimed at simplifying the fees charged by Afssaps.
The new conditions took effect on 1 January. An amendment to France’s 2006 budget had capped the total fees payable for Afssaps and ethics committee approval of clinical trials at €6,000 per application.