Raine to step down after leading MHRA through Brexit, COVID-19

June Raine is set to step down from her position as chief executive of the UK Medicines and Healthcare products Regulatory Agency (MHRA) after serving in the role for five years and leading the agency through Brexit and the COVID-19 pandemic.

“The Department of Health and Social Care (DHSC) will shortly begin recruitment for a new Chief Executive,” MHRA said in a 26 February statement. “Dame June will remain in post until the Autumn to ensure a smooth transition to her successor.”

Raine came into office at a critical time, only four months before the UK pulled out of the European Union under Brexit, leading to a sea change in regulations as MHRA is no longer under the oversight of the European Medicines Agency (EMA). Her appointment was followed just a few months later by the COVID-19 outbreak, leading the agency to scramble to find drugs, vaccines, and diagnostics to address the global pandemic.

“I am especially proud that during the last five years, the agency has built a new vigilance system, strengthened international and national partnerships, and delivered regulation which has enabled groundbreaking innovation, from gene therapy for sickle cell disease and the world’s first Covid vaccine, to being close to eradicating polio, and from medical device software to AI diagnostics,” said Raine. “While I am stepping back from my MHRA role, I hope still to be involved in contributing to patient safety and public health in other ways.”

Raine recently participated in a Q&A interview with the US Food and Drug Administration (FDA) about how her agency has transitioned from its oversight under EMA due to Brexit and the importance of partnering across the pond. One area she singled out is MHRA's collaboration with FDA in developing regulations around artificial intelligence/machine learning (AI/ML).

Raine began at MHRA’s predecessor, the Medicines Division, in 1985. From 2006 and until she was named chief executive, she served as director of Vigilance and Risk Management of Medicines.

Raine served as chair of the European Pharmacovigilance Risk Assessment Committee (PRAC) on behalf of EMA from 2012 to 2018. Until recently, she also served as co-chair of the World Health Organization’s (WHO) Advisory Committee on Safety of Medicinal Products.

MHRA statement

Raine to step down after leading MHRA through Brexit, COVID-19

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