Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.
"Although negotiations on the terms of the UK's departure have not yet officially commenced and one cannot prejudge their outcome, work will now start on the basis of the scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory system as of 30 March 2019," EMA said on Friday.
The agency noted that some general principles for workload distribution will include: ensuring continuity; maintaining the quality and robustness of scientific assessments; continuing to comply with legal timelines; ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer.
"The envisaged working methodology will include a mapping of current and future capacity and expertise in the network and the identification of potential gaps. This could help the network to increase its capacity in selected areas, and would be supported with enhanced training opportunities," the agency added.
Member state representatives will determine where the agency's headquarters move and EMA said it welcomes the interest expressed by some member states in hosting the agency in future.
"EMA is confident that the member states will make the most appropriate decision on the agency's location and arrangements, taking the complex political and legal environment generated by the outcome of the UK referendum into account," the agency said.
Statement
Tags: Brexit, EMA headquarters, EMA move