The European Medicine Agency (EMA)’s Management Board met earlier this month and in addition to reviewing 2016 achievements, key topics of discussion were Brexit preparations and the EU Clinical Trial portal and database.
Preparation for the UK leaving the European Union is underway and is focussing on
- relocating the EMA from London. The European Council will decide on the new location in October 2017.
- the allocation of the EMA’s workload across the network and streamlining process, whilst maintaining high quality scientific assessment and complying with specified timelines.
- providing advice and guidance to industry on actions required to ensure their marketing authorisations are still valid following Brexit and the supply of medicines will not be disrupted.
The EMA is working on the basis that on 30 March 2019 the UK will become a third country (a country outside the European Union and European Economic Area). This stance may be adjusted in the light of negotiations. In the meantime, the UK is continuing its normal role in EMA activities.
The EMA’s achievements in 2016 include:
- launching PRIME (PRIority MEdicines) a scheme to support the development of medicines that target an unmet medical need;
- introducing a website to publish clinical data for new medicines;
- completing a pilot joint scientific advice with health technology assessment (HTA) bodies;
- work to combat antimicrobial resistance.
The introduction of the EU Clinical Trials portal and database is delayed until 2019. See our separate news item here for further details.