Clinical trial fee suspended
Paris – Researchers in France no longer have to pay fees to register clinical trials with the French national medicines regulator Afssaps. Until January 1st of 2009, sponsors were required to ante up a6,000 for every trial application submitted to the regulatory agency for approval.
The fee first became a condition for filing a clinical trial application with Afssaps and the relevant ethics committee (CPP) in August of 2006. Its removal was part of France’s national budget for 2009, which included a number of measures aimed at simplifying the fees charged by the regulator. Clinical trials sponsors are however still required to obtain a EudraCT registration number from the European Medicines Agency before forwarding their applications to Afssaps or to an ethics committee. The French government hopes that the move will help stimulate the transfer from the lab to clinical development, especially for small and medium-sized biotech companies.