Since 1995, the European Medicines Agency (EMA) has progressed from harmonising regulation
for human and veterinary medicines across the European Union Member State national
competent authorities, to galvanising one of the most successful cooperative initiatives
for regulation globally. Although the EMA is the focal point for stakeholders, regulation
is delivered through the European medicines regulatory network, in which national
authorities, like the UK’s Medicines & Healthcare products Regulatory Agency (MHRA),
contribute. As with any collaboration, contributions by individual members vary, and
the MHRA has been noted as an innovative and highly productive member of the network.
Progress in regulation not only in Europe – but also around the world through convergence
– can be attributed to this unique European cooperation. The decision by the UK to
leave the European Union threatens to mark the end of this cooperation; we argue here
that the best decision is to maintain regulatory cooperation under new structures.