New UK authorisation policy draws on international drug approvals

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The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition procedure (IRP) will allow it to draw on the expertise of regulators in other countries when authorising medicines.

The MHRA will retain ultimate authority to accept or reject applications submitted under the IRP, but it is hoped that this approach will result in a more rapid, efficient, and cost-effective process.

However, the pharmaceutical industry has questioned how competitive the new scheme is compared to the current national procedure.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: “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.”

Reduced time for drug applications

The MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area).

Applications under IRP can be received via the MHRA website under one of two recognised routes, A and B. Time horizons for authorisations are set at 60 to 110 days – which the MHRA says is considerably shorter than the current 150-day time horizon for applications.

The MHRA launched an ‘Eligibility Checker’ tool in November 2023, which allows applicants to determine whether their Marketing Authorisation Application (MAA) is suitable and to identify which route to follow.

In a blog post on September 2023, Dr Daniel O’Connor, Director of Regulatory and Early Access Policy, Association of the British Pharmaceutical Industry (ABPI), discussed the IRP proposals. “The IRP is an additional flexibility for medicine developers, which may offer some added value for products approved in other jurisdictions,” he said. “However, due to the extensive B criteria, most innovative products will likely fall under Recognition B, where the ‘Day 110 approval pathway with clock stop’ is not particularly competitive versus the national procedure.”

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