UK's MHRA steps up to the plate as no-deal Brexit looms

As the UK’s political leadership continues to signal its intention to leave the European Union at the end of October, “come what may,” the country’s medicines regulator is getting ready to enter the big leagues.

If the UK leaves the EU without a deal, the Medicines and Healthcare products Regulatory Agency (MHRA) will become the UK’s standalone medicines regulator, taking over all functions currently undertaken by the European Medicines Agency (EMA).

In a  statement issuing guidance for drugmakers, the MHRA noted that this includes decisions on marketing authorization applications.