UK COVID-19 inquiry|27 May 2025

Dame June Raine. Chief Executive of the MHRA.

Introduction

Dame June Raine is CEO of the Medicines and Healthcare products Regulatory Agency (MHRA). She came to wider public prominence in December 2020, when the MHRA was the first regulator to approve an mRNA vaccine for use in humans. She was appointed Dame Commander of the Order of the British Empire (DBE) in the 2022 New Years Honours for services to healthcare and the COVID-19 response and after forty years at the MHRA will leave the post in the Autumn.

‘‘The overall lesson learnt on preparedness in the area of MHRA's scientific expertise is that it is vitally important that there is continued investment in MHRA's capability for pandemic preparedness if the government's '100 Days Mission' aim of accessing diagnostics, vaccines and therapeutics within 100 days of a pandemic being declared is to be achieved.’’

-Pargraph 189 of statement

Testimony higlights

• ‘‘Approval’’ of Lateral Flow/PCR ‘medical devices.’

• Exceptional use authorisation powers used 17 times.

• Quality control exemptions.

‘Our tool we used EXTENSIVELY during the pandemic exceptional use authorisations we used that for those types of particular diagnostics.’’

‘‘The agency didn’t approve testing kits..it regulated them.’’

‘‘During the pandemic we were able to use the power to EXEMPT companies from needing to meet those standards and requirements.’’

Note: CA marking became UK law 31 December 2020.

Ready for COVID?

‘‘COVID-19 was one of the virus scientists in our laboratories had been READY to look for.’’

WHO agreement

The recent agreement with the WHO is discussed.

‘‘The agency is already looking at reforming the law on medical devices.’’

‘‘No one is safe until everyone is safe.’’

Void test results/supermarket sandwich bags

‘‘We (MHRA) wouldn’t have had a responsibility for this.’’

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