The EMA published a press release on 16 June 2017, announcing the entry of force of the Clinical Trial Regulation has been delayed until 2019. At the EMA management board meeting on 16 June, the progress in the development of the EU portal and database were discussed. Technical difficulties in the development of the IT systems have delayed the go live date of the EU portal. At the next board meeting in October, the Agency will provide progress on development as well as a new launch date. The EMA is committed to providing a high quality and efficient system to its stakeholders and therefore has agreed to a delay of the launch of the EU portal. Consequently, the EU Clinical Trial Regulation will come into force in 2019, instead of October 2018.
The EMA is modernising the process for authorisation and oversight of clinical trials in the EU by implementing the EU portal and database. The portal provides a single point of access, submission and maintenance of clinical trial applications and authorisations as well as support assessment and supervision. The portal will also provide access to the public on information on the full life cycle of the clinical trial process in the EU. This will include initial review to the final results of each trial, to provide greater transparency to consumers and general public.