title: What you Need to Know about the New Regulations for Biomedical Research in France.
abstract: The EC 2001/20 directive relating to the clinical trials of medicinal products was transposed into French law in 2004 by means of a public health law. But this transposition actually came into effect on 27 August 2006 by the implementation of decree no. 2006-477 of 26 April 2006 which has been followed subsequently by numerous statutory orders. A reading of these regulatory texts shows that the new provisions go far beyond the framework of the directive as they have been notably extended by the French legislator to encompass all the health products within the competence of the French Agency for Sanitary Safety in Health Products (Afssaps) as well as to other studies that do not involve health products. In addition, all research undertaken is from now subject to the prior, and jointly favourable, reasoned opinion of a CPP (Ethic Committee) and authorisation by Afssaps. These new regulations for biomedical research in France substantially modify and reinforce the previous provisions defined by the Huriet law of 1988, for safety, vigilance and traceability.
authors.affiliation: White-Tillet, Consultants & Experts, Chelles, France. Electronic address: white-tillet@white-tillet.com.
authors.forename: Yves
authors.initials: Y
authors.lastname: Tillet
authors.affiliation: Appamed, Clichy, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Lebrun
keywords: biomedical research; clinical trials; procedures; regulations; safety; traceability; vigilance