MHRA’s post-Brexit mutual recognition framework goes live

Calvin Hanson

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the UK more quickly.

The International Recognition Procedure (IRP) – which went live on 1st January – means that the MHRA can take into account the expertise of trusted regulatory partners in other countries when reviewing applications for new medicines that have already been authorised elsewhere.

It has been implemented following the UK’s departure from the EU and replaces the European Commission’s centralised procedure (ECDRP), which came to an end on 31st December last year.

It works the other way as well, allowing the exchange of information with regulators in the EU, the US, Japan, Australia, Canada, Switzerland, and Singapore. According to the MHRA’s interim executive director of healthcare quality and access, Julian Beach, it has created “a ‘win-win’ for regulators, developers of innovative treatments, and patients.”

The agency also stressed that it retains ultimate authority to accept or reject applications submitted under the IRP. It includes two routes, A and B, which have the time available to review authorisations set at 60 and 110 days, respectively. It says that is considerably shorter than the current 150-day target for applications.

For drugmakers, the IRP introduces regulatory flexibilities for companies to consider when applying for their products to enter the UK market, according to the Association of the British Pharmaceutical Industry (ABPI).

The trade organisation has broadly welcomed the addition of a new route to regulatory approval, but pointed out in a recent blog post that most innovative products will fall under category B – which can have reviews paused via a ‘clock stop’ – and concluded that the new system “is not particularly competitive versus the national procedure (or as favourable as compared to the ECDRP).”

Health Minister, Andrew Stephenson, said the announcement “shows how organisations can maximise Brexit freedoms, accelerating patient access to new medicines on the NHS and putting the UK on the forefront of medical innovation.”

He added: “We’re making it easier than ever for patients to receive the life-saving medicines they may need, faster.”

The MHRA launched an Eligibility Checker tool in November to help drugmakers consider the new pathway. Six weeks before making a full submission under the IRP, they should use this tool to determine whether their application is suitable and to identify which route to follow.

Photo by Calvin Hanson on Unsplash