Massive Reallocation of UK Rapporteurships Likely As EMA Plans For Future; UK’s Interim Role Uncertain

If Brexit means the UK no longer plays a part in the EU drug regulatory system, responsibility for the ongoing oversight of almost one in four of all the human medicines that have ever been approved under the centralized procedure will have to be reassigned from the UK to other member states. What Brexit means for the UK’s role as a key player in the regulatory system in the meantime is the subject of speculation.

Brexit concept
The MHRA's rapporteurships could be headed elsewhere in the EU

Between now and the UK’s departure from the EU at the end of March 2019, the European Medicines Agency may have to reassign as many as 230 human-use medicines for which the country has acted as rapporteur or co-rapporteur in the centralized approvals procedure. This is just under one in four of the almost 1,000 medicines approved centrally since the current system came into operation in 1995.

There are also questions over how far the UK can continue to be chosen as the lead or co-lead regulator...

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