UK could allow reciprocal drug approvals with US FDA as soon as 2024
An intellectual property law firm says that recent guidance from the UK’s Medicines and Healthcare products Regulatory Agency hints at the possibility of the agency allowing approvals from other regulators, including possibly the US FDA, to play a role in UK regulatory processes.
Marks & Clerk, based out of London, wrote in a blog post that guidance from the UK’s regulatory agency from late January is providing more context into potential international collaboration with other regulators. How that would come about is after the UK’s “Reliance Procedure” — a way to ensure patients in Great Britain post-Brexit could still access new medicines — expires.
The procedure, in short, allows MHRA to utilize positive EC decisions to fast-track the approval process for marketing authorizations in Great Britain. Back in September, the agency announced that the procedure would be extended through the end of 2023.
As for what would be next, the MHRA put out word on Jan. 24:
From 1 January 2024 you can apply to MHRA through our new international recognition framework, which will have regard to decisions already made by the European Medicines Agency and certain other regulators.
The law firm added at the time that it remains to be seen which regulators would be included in the new system, but it referenced the similarity of international collaboration akin to Project Orbis — a program set up by the FDA in 2019 to collaborate with different international agencies on submission and review of cancer treatments. The project now includes regulators from the US, UK, Australia and five other authorities.
The firm added that the announcement would “no doubt be welcome news to companies who see Great Britain as a key part of a multi-jurisdictional launch strategy.” The firm additionally noted that allowing the MHRA to essentially “piggy-back” on authorizations from other regulators could have advantages.
While FDA did not comment to Endpoints News before deadline, the MHRA only reiterated what it had said before: “We will communicate who these additional regulators are and publish detailed guidance about this new framework in due course, including any transition arrangements for applications received under existing frameworks.”