UK Regulator Has Key Role in One in Four EU-Wide Approvals
The extent of the UK medicines regulator’s involvement in the European regulatory network shows how complicated disentangling the UK from the system would be.
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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.
The UK has formally notified the EU of its plans to leave the trading bloc and formal Brexit talks will begin soon. In the meantime, pharmaceutical regulators in the remaining 27 EU member states are having to plan for a future without the UK regulatory agency, the MHRA. In the UK, “Day 1” of Brexit is focusing minds.
The role of the UK drug regulator in the EU post-Brexit will depend on the outcome of complex negotiations. It’s clear that the loss of the MHRA from the network would be keenly felt by other agencies across Europe.