March 22, 2019

Update from the European Medicines Agency

by Jose Drabwell

The European Medicines Agency (EMA) currently based in London (UK) will be moving in March 2019 to Amsterdam (the Netherlands), following the decision of the UK to leave the European Union. This decision and the subsequent move has had an impact on the EMA that has reduced its activities to focus on the relocation to Amsterdam and on the authorisation, maintenance and supervision of medicines. This has also translated that the meeting organised with patient organisations and healthcare professionals in December was virtual, as well as the meeting on the future European clinical trials portal.

Virtual meeting of patient and consumer organisations and healthcare professionals
13 December 2018

Participants to the virtual meeting were informed and updated on the progress made in several aspects, being the key one the EMA relocation to Amsterdam while trying to safeguard core activities. The Agency will need to review its rules of procedures, the mandates of those persons replacing UK professionals as well as the physical meetings to be held as of March 2019 in the new location. The Agency has also been providing pharmaceutical companies with some guidance and the British authorities as well with the view of trying to avoid shortages or scarcity of medicinal products after the UK leaves effectively the EU.

The European Medicines Agency is also working in developing the key principles to implement the electronic product information, to provide a digital platform for the information related to medicines authorised in the EU, how they should be used and prescribed in the different European languages. As a way of gathering public opinion, the EMA has launched a consultation on this subject (deadline 31 July 2019). Another consultation that was also recently launched was on Regulatory science to 2025, which places as a goal to advance on patient-centred access to medicines. This consultation is open until 30 June 2019.

On-going work on the European clinical trials portal and database
6 December 2018

The EMA continues to collaborate with member states representatives, pharmaceutical companies, healthcare professionals and patient organisations to develop the system that would enable the creation and use of the European clinical trials portal and database, as established in European legislation. At present, the focus is on the last phase of the software testing process, to ensure the software can handle the requirements in real scenarios according to what was settled in legislation.