Numéro |
Therapie
Volume 70, Numéro 1, Janvier-Février 2015
XXXes Rencontres nationales de Pharmacologie et Recherche clinique, pour l’Innovation et l’Évaluation des Technologies de Santé Tables rondes GIENS – 5 au 6 octobre 2014
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Page(s) | 29 - 36 | |
Section | Le système de réglementation / Regulatory system | |
DOI | https://doi.org/10.2515/therapie/2014234 | |
Publié en ligne | 16 février 2015 |
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
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.
Key words: European regulation on clinical trials on medicinal products for human use / transparency / methodological evaluation of authorization applications / Jardé Act / French Data Protection Act / Ethics Committees / ANSM / medical devices
© 2015 Société Française de Pharmacologie et de Thérapeutique