The European “Clinical Trial” Regulation; Relationship with the Jardé Act: a Giens Workshop

¹ Université Paris Est, Créteil, France
² Laboratoire Roche, Boulogne Billancourt, France
³ Université Paris Diderot, Paris, France
⁴ Assistance Publique – Hôpitaux de Paris, Paris, France
⁵ Laboratoire AstraZeneca, Rueil Malmaison, France
⁶ Laboratoire Boehringer-Ingelheim, Reims, France
⁷ AFCROs, Axonal, Nanterre, France
⁸ ANSM, Saint Denis la Plaine, France
⁹ Centre d’Investigation Clinique, Clermont-Ferrand, France
¹⁰ Medtronic, Boulogne Billancourt, France
¹¹ CNCPP, Paris, France
¹² Eval Santé, Croissy-sur-Seine, France
¹³ Voluntis, Suresnes, France
¹⁴ Hospices Civils, Lyon, France
¹⁵ LEEM, Les Entreprises du Médicament, Paris, France
¹⁶ Laboratoire Glaxosmithkline, Marly-le-Roi, France
¹⁷ Laboratoire Novartis, Rueil Malmaison, France

Correspondence and offprints: François Lemaire, 92 rue d’Alésia, 75014 Paris, France. E-mail: f.lemaire@numericable.com

Received: 14 November 2014
Accepted: 6 December 2014

Abstract

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency.

Abbreviations: see end of article.