New clinical trial regulation under way

12 January 2016

The European Medicines Agency (EMA) is developing a new EU database and EU portal that will make it easier for companies to apply for clinical trials of medicines.

When the regulation comes into effect, applicants will have access to a single portal for submission of applications via one EU portal and one central database instead of having to apply in each member state as is the case today. This also applies to amendments to clinical trials. The EU portal and database will also be accessible to the public and provide information about clinical trials conducted in the EU.

We previously announced that the new EU Clinical Trial Regulation would come into effect in 2017, but the launch date has been postponed until 2018, because the new portal and database are not yet available.

At the EMA’s Management Board meeting held on 17 December 2015, the Board endorsed the time frame for the implementation of the EU portal and database. The time frame foresees that the EU database and portal are available for independent audit by August 2017. If the system gets a green light from the audit, the EU Clinical Trial Regulation will come into effect in October 2018.

This is a maximum time frame, and the EMA, the EU Commission and the member states will make an effort to shorten the time frame.

The new EU regulation will imply changes to the way the Danish Medicines Agency and the research ethics committees authorise and monitor clinical trials of medicines.

The Danish Ministry of Health has recently submitted a proposed law on clinical trials of medicines for consultation, including proposals for how to incorporate the new EU regulation into the Danish legislation.


Read more about the EU Clinical Trial Regulation 536/2014 on the EMA’s website

The new Danish proposed law on clinical trials is published on the Danish consultation portal (Høringsportalen) (in Danish)