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
Details
- Publication date
- 3 June 2014
- Author
- European Medicines Agency