Update to the EU Directive 536/2014 and Brexit

Posted by Dr. Grit Andersen on Jul 21, 2017 4:30:00 PM

If you have been following our blog, you have been reading quite a lot about the European new clinical trial regulation adopted on 16 April 2014. We have already discussed the changes on clinical trials, the pilot project in Germany and the challenges Germany is facing due to the implementation of this project. 

Since EMA's management board had another meeting last June, we have new updates to share with you! During the last meeting decisions were made regarding the consequences of the Brexit for the EMA, the physical relocation of the Agency and new changes to the directive timeline.



EMA is preparing itself for the withdrawal of the United Kingdom from the European Union. In this matter, it is expected that the UK will become a third country after 30th of March 2019. However, the UK will continue to participate in all formal meetings and retain its full voting and speaking rights.

EMA's physical relocation

As the United Kingdom is leaving the EU, the European Medicines Agency is preparing to move its headquarters to one of the other 27 Member States of the European Union. The Agency will try to maintain as many staff as possible after moving, however it has to prepare itself for the likely event of losing a significant number of staff members. The relocation decision is expected by October 2017.

Germany has submitted its application for the movement of the EMA to the European Rhine Region, namely to the city of Bonn in with the potential new address Bundeskanzlerplatz 2-10. Further details can be seen here:

Another 17 countries have submitted their application for hosting the EMA, such as:  Austria (Vienna), Netherlands (Amsterdam) as well as Sweden (already the location of the European Center for Disease Control and Prevention!), Denmark, Finland (already the location of the European Chemicals Agency), Spain, France, Ireland, Poland and Italy (

The whole procedure to decide on the new location of the European Medicines Agency consists of 4 different steps:

  • Submission of Member States offers by 31 July 2017;
  • Commission evaluation of the offers using predefined and agreed criteria by 30 September 2017;
  • Political discussion based on the evaluation of the Commission will take place in October 2017;
  • EU Ministers will vote and decide on the new location for the EMA in November 2017.

Other issues related to Brexit

A re-distribution of the EMA’s workload regarding the evaluation and monitoring of medicines has been initiated. There will be two main workgroups: one for human medicine and one for veterinary medicine. With this new division, the agency hopes to further improve the efficiency and effectiveness of its work. 

Moreover, guidance was published to help pharmaceutical companies to check, review and adapt their processes to ensure continuous supply of medicines to patients.

Changes to the timeline for the implementation of the EU Directive 536/2014

In addition and due to other reasons the implementation of the EU Directive 536/2014 is postponed to 2019 instead of October 2018.

Technical difficulties with the development of the IT systems are the reasons for the postponement of the portal’s go-live date. EMA is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress. The EU Board was informed about the mitigation measures taken and the revised plan from the developer. The agency will provide an update at the next meeting of the management board in October 2017 where a new delivery time frame will be discussed once progress with development has been confirmed.

This is the most ambitious IT system required by the EU legislation in the last decade, involving a complete EU-wide system to be used for clinical trial applications, urgent safety measures and other notifications to regulators before, during and after the conduct of clinical trials.

As we can see, the European Medicines Agency (EMA) is taking steps to streamline its work process and improve its own work flow in the wake of Brexit.

Topics: Clinical Trials in Diabetes