France eliminates clinical trial application fees
This article was originally published in SRA
Researchers in France no longer have to pay fees to register clinical trials with AFSSAPS, the national medicines regulator1. A provision in the country’s budget for this year took effect on 1 January, eliminating two fees that cost sponsors up to €6,000 per trial application. The changes are aimed at simplifying procedures.
Payment of the fees became a condition for filing clinical trial applications in 2006. The agency imposed a variable fee based on the complexity of the application and it collected an additional fee on behalf of the ethics committee responsible for overseeing the trial. The fees were payable for all clinical trials and treatment studies, and for projects involving the handling of human tissues and other biological samples. Researchers in public institutions and in the nonprofit sector were charged at 10% of the standard rate.
The agency notes that for all clinical research (with the exception of human medicines), sponsors must obtain a registration number from AFSSAPS before submitting their applications. Sponsors of trials for human medicines have to obtain their registration number from the European Medicines Agency’s clinical trials database, EudraCT.
The 2009 finance legislation repeals AFSSAPS’ 25 August 2006 order on clinical research fees.
References
1. AFSSAPS press release, 1 January 2009, http://agmed.sante.gouv.fr/htm/3/rcb/indrcb.htm