Volume 65, Numéro 4, Juillet-Août 2010
|Page(s)||301 - 308|
|Section||Affaires réglementaires / Regulatory System|
|Publié en ligne||21 septembre 2010|
Clinical Trials Legislation - Preparing for the Revision of the European Directive Scheduled for 2011
Laboratoire Boehringer Ingelheim, Reims, France
2 Afssaps, Saint-Denis, France
3 Centre d’Investigation Clinique, Hôpital Jeanne d’Arc, Dommartin les Toul, France
4 Direction Générale de la Santé, Paris, France
5 Laboratoire Pfizer, Paris, France
Correspondence and offprints : Pascal Bilbault, Recherche
Clinique Boehringer Ingelheim France, 12 rue André Huet, 51060 Reims Cedex, France.
Accepted: 23 April 2010
The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive’s dispositions could be improved, such as the definition of “investigational medicinal products” (IMP) and what should be considered as “substantial amendements”, as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states.
Other points in the Directive do require revision, especially those relating to:
the definition of the respective roles of Ethics Committees and Competent Authorities,
the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report),
the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational.
Key words: clinical trials / european Directive / biomedical research / revision / risk
© 2010 Société Française de Pharmacologie et de Thérapeutique