Lemaire François, Marchenay Brigitte, Chassany Olivier, Barthélémy Philippe, Bouzzagou Mohamed, Comet Denis, Delval Cécile, Dubray Claude, Fouret Cécile, Frija-Orvoen Elisabeth, Gambotti Laetitia, Lamarque Véronique, d'Orsay Geneviève, Plattner Valérie, Sibenaler Claire, Roux Jacques, Thoby Frédérique
Université Paris Est, Créteil, France.
Laboratoire Roche, Boulogne Billancourt, France.
Therapie. 2015 Jan-Feb;70(1):21-36. doi: 10.2515/therapie/2014234. Epub 2015 Feb 16.
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.
2014年5月，欧盟议会和理事会发布了一项关于人类用药品临床试验的新法规，旨在取代2001/20/EC号指令。该法规要到2016年才会生效。然而，审视其与国家立法（即《雅尔代法》）的关系至关重要，在欧洲法规发布之前，《雅尔代法》的实施已被推迟。吉扬研讨会确定并研究了这种关系必然会引发的各种问题。特别是，它审视了试验方法评估程序、法国国家药品和保健品安全局（ANSM）与伦理委员会在授权申请评估阶段的工作关系、药品和医疗器械上市后/注册研究的审查以及数据透明度。
