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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article3 June 2014European Medicines Agency

Publication of the Clinical Trials Regulation

The Clinical Trials Regulation was published on 27 May 2014 in the Official Journal of the European Union (EU). The new legislation will not come into force until the necessary IT platforms to support the exchange of information are in place (see Articles 80 and 81). This is anticipated as being no earlier than mid-2016.

Related information:

» Official Journal of the European Union, L158/27 May 2014

» European Medicines Agency welcomes publication of the Clinical Trials Regulation


Publication date
3 June 2014
European Medicines Agency