Today, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) handles a sizable slice of EMA's workload. EMA will lose access to that capacity on 30 March 2019 unless the UK and European Union agree a temporary or permanent agreement that keeps MHRA in the agency. If the clean split goes ahead as anticipated, EMA will need to find additional capacity and expertise from elsewhere to continue providing uninterrupted, unaffected regulatory services.
EMA has put responsibility for laying the groundwork for such a smooth transition on two working groups, one for human medicines, another for veterinary medicines. The tasks facing the groups are similar. EMA expects the groups to distribute the workload for processing of initial marketing authorization applications, scientific advice and pharmacovigilance procedures. The changes to the handling of marketing authorizations include the reassignment of procedures that are yet to start but have been allocated to the UK.
The working groups will figure out how to redistribute this work using responses from surveys EMA is planning to run. EMA wants to conduct the surveys to better understand current and future capacity at the regulatory bodies of member states. This should reveal where gaps exist and whether member states are willing to invest to build out their capabilities.
EMA thinks the best approach to redistributing the regulatory workload will differ between the two sectors, but it wants the groups to work from a shared set of principles.
The top item on the list of principles endorsed by EMA's management board is to "ensure business continuity and proportionality in the distribution of workload." In doing so, the working groups should take the expected date of Brexit in 2019 and the average timelines for different regulatory procedures into account. Other related criteria are that the redistribution must allow EMA to meet legally required timelines and maintain its standards.
EMA's desire to avoid losing knowledge gets its own spot on the list. The agency thinks that could be achieved either by building on existing knowledge or through knowledge transfer. Either way, the goal is to ensure EMA is as equipped to do its work the day after Brexit as it is today. The agency is also looking beyond the Brexit deadline. One objective of the working groups is to distribute the workloads in a way that equips EMA to prosper long after Brexit.
That objective is secondary to the main goal of preventing a disruptive transition. To that end, EMA wants the working groups to develop implementation plans with specific timelines for reassigning work in advance of 30 March 2019. Those plans may include operational changes at EMA.