The scenario the U.K. is trying to avoid is a full disconnect from EMA when the Brexit curtain falls. But a clean break from the agency could create opportunities for the U.K.’s Medicines and Healthcare products Regulatory Agency to fast track innovation in areas where the country has scientific expertise.
In particular, two industry representatives and one former MHRA official think the agency could become a regulator of choice for cell and gene therapies and real-world trials.
Negotiations between the EU and U.K. are still at the early stages, and politicians in Britain, along with industry on both sides of the Channel, remain hopeful that a close partnership between the two agencies can be reached.
But for now, EMA appears to be interpreting the EU Council’s draft Brexit guidelines to mean that after the U.K. becomes a “third country,” MHRA will be unable