Entry into force of EU Clinical Trials Regulation postponed to 2019
On 16 June 2017, the European Medicines Agency (“EMA”) published a press release1 announcing the postponement of the entry into force of the EU Clinical Trials Regulation of 16 April 2016.2 It was one of the topics at the June 2017 meeting of the EMA Management Board.
The objective of the Regulation is to harmonize the procedures for clinical trials between the Member States of the EU. It also guarantees greater transparency in the execution of the clinical trials through the EU portal that will be set up for this purpose. This portal will serve as a focal point for the submission of data and information about clinical trials. The data that are submitted via the EU portal will then be saved in the EU database.
According to the Regulation, it will enter into force six months after the publication of the communication from the Commission that the EU portal and the EU database on clinical trials have become functional. The deadline for putting in place the IT systems was originally set for October 2018. However, according to the EMA, technical difficulties are affecting the development of the portal and the database, resulting in a delay in the implementation of the portal and the database. As a consequence, the entry into force of the Clinical Trials Regulation is now scheduled for 2019.
The EMA will provide an updated time frame after the next meeting of the Management Board in October 2017.
1 European Medicines Agency, Media and Public Relations, “EMA Management Board: highlights of June 2017 meeting ‘Focus on Brexit preparations and the development of the EU clinical trial portal and database’”, EMA/365003/2017, 16 June 2017 http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/06/WC500229512.pdf.
[2] Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.
