The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop

Therapie. 2015 Jan-Feb;70(1):21-36. doi: 10.2515/therapie/2014234. Epub 2015 Feb 16.
[Article in English, French]

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.

MeSH terms

  • Access to Information / legislation & jurisprudence
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Clinical Trials as Topic / standards
  • Computer Security / legislation & jurisprudence
  • Ethics Committees, Clinical / legislation & jurisprudence
  • Ethics Committees, Clinical / organization & administration
  • Ethics Committees, Clinical / standards
  • Ethics Committees, Research / legislation & jurisprudence
  • Ethics Committees, Research / organization & administration
  • Ethics Committees, Research / standards
  • European Union
  • France
  • Government Agencies
  • Human Experimentation / legislation & jurisprudence
  • Humans
  • Language
  • Medical Device Legislation
  • Observational Studies as Topic / legislation & jurisprudence
  • Research Design / standards