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Advancing healthcare policy

Clinical trials and Europe

Clinical trials and Europe: The Legislative Process

The EU regulation on clinical trials was jointly adopted by the European Parliament and the Council, following the ordinary legislative procedure.
 

The European Commission, the European Parliament and the Council of the Member States’ Health Ministers were all involved in the development of the European clinical trials legislation.

Principal steps of the legislative process

17 July 2012:
Initial proposal by the European Commission > Pdf, 348 Ko

29 April 2013:
Amendments adopted by the European Parliament’s Commission for Environment, Public Health and Food Safety (ENVI) > Pdf, 1 318 Ko

20 December 2013:
Joint position by the Council > Pdf, 568 Ko

16 April 2014:
Regulation (EU) No 536/2014 on clinical trials, final version > Pdf, 765 Ko

For more information:

> Procedure file, available online

©Prescrire November 2014