• Leader of the Medicines and Healthcare products Regulatory Agency to step down in September 2019
  • If the UK exits the EU without a deal, the MHRA will be a “stand-alone medicines and medical devices regulator” from March 2019
  • Ian Hudson said “the time was right” for a new person to lead the agency through the UK’s EU departure

The chief executive of the UK’s medicine regulator is to leave his post in September 2019, six months after the UK is due to leave the European Union.

Ian Hudson has led the Medicines and Healthcare products Regulatory Agency for six years and has worked at the agency for almost two decades.

Dr Hudson said he was stepping down for “personal and professional” reasons, including wanting to reduce his workload.

He said: “The time is right for a new person to guide the agency and our work through its next phase, following the UK’s departure from the European Union next year.

“Our agency makes a real difference to the health of millions of people in the UK, Europe and beyond, and it has been an honour to be part of that.”

His departure comes at a time when the MHRA could take on a much higher workload as the UK prepares to leave the EU.

In the event of a no-deal Brexit, the government has said: “The MHRA would be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU level.”

It added this could include “new innovative licensing routes”, new global partnerships and a review of fee structures.

However, the draft withdrawal agreement presented by prime minister Theresa May last week said the UK would continue to be part of EU medical regulation process until a proposed transition period is over.

The document said the MHRA would not be able to act as the leading authority for new risk assessments, approvals or authorisations of drugs and medical devices during the transition period, but it must agree to implement the outcomes of any assessments.

Neither the EU nor the UK government has yet ratified the withdrawal agreement.