Brexit could cut off EMA from U.K. expertise
While there is great uncertainty about the impact of a Brexit on British life sciences companies, the problems posed to the European regulatory system are clearer. Brexit could slash or eliminate MHRA's role in EMA, drying up one of the agency's biggest pools of scientific and regulatory expertise.
Among the many perplexing challenges for the EU, figuring out how to replace MHRA experts may be among the most pressing.
This is because the U.K. agency has played an outsized role in European drug regulation, providing rapporteurs and co-rapporteurs - leaders and co-leaders of scientific evaluations - for a high percentage of marketing authorization applications (MAAs), chairing and playing active roles in EMA committees, and providing scientific advice to inform drug development.
Under the most likely Brexit scenarios, the U.K. would no longer be able to lead some or all of these activities, and EMA's headquarters would be moved from London to an EU member state.
In addition, a U.K. exit would likely make it necessary to transfer marketing authorizations registered in the U.K. to an entity in an EU member state, according to attorneys specializing in