Global expertise from the MHRA's international recognition procedure

New MHRA procedure to harness global expertise and streamline applications for medicine manufacturers

A new application procedure launched by the Medicines and Healthcare products Regulatory Agency (MHRA) is set to help deliver life-saving treatment to NHS patients sooner.

The new international recognition procedure (IRP) is a licensing route for medicines that allows the MHRA to conduct targeted assessments by acknowledging approvals from similar organisations around the world.

Regulators in Australia, Canada, Japan, Singapore, Switzerland and the United States are among those who the MHRA will partner with now the IRP has gone live.

The IRP has been developed following the UK’s departure from EU and, as of 1 January 2024, replaced the European Commission’s decision reliance procedure.

While the MHRA retains the authority to accept or reject medicines, the “global expertise” derived from the IRP is expected to streamline the process for applicants.

Andrew Stephenson quote

The IRP is open to applicants that have already received an authorisation for the same product from one of the MHRA selected reference regulators – i.e., Australia’s Therapeutic Goods Administration, the Food and Drug Administration in the United States, or Health Canada.

The MHRA’s interim executive director of healthcare quality and access, Julian Beach, said: “With this new application procedure fully live, we are delighted to have created a further, innovative route for bringing new medicines to UK patients.

“IRP allows us to access the expertise of trusted regulatory partners, who have already authorised products. In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients.”

Time horizons for approvals are set to between 60 to 110 days, depending on which recognition route is pursued. The MHRA launched a tool to help applicants identify which route would be best to follow last November.

“We’re making it easier than ever for patients to receive the life-saving medicines they may need, faster,” said health minister, Andrew Stephenson.

“This new international recognition procedure will speed up the licensing process by allowing access to the expertise of other trusted regulatory partners, including those in Australia, Canada and Switzerland.”

Image credit: iStock

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NHE May/June 2024

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