The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new recognition routes for medicines which have been approved by trusted regulatory partners in:

  • Australia
  • Canada
  • European Union
  • Japan
  • Switzerland
  • Singapore
  • United States

These recognition routes will be part of the new international recognition framework for medicines that the MHRA is currently establishing using the £10 million awarded by the HM Treasury in March 2023. According to the MHRA, the new international recognition framework will be in place by the first quarter of 2024.

Background

Since 1 January 2021, marketing authorisations (MAs) issued by the European Medicines Agency (EMA) do not apply in Great Britain (England, Scotland, Wales).

Instead, medicines now need to be granted an MA by the MHRA in order to be marketed in Great Britain. To ensure continued access to new medicines for patients in Great Britain, the MHRA has put temporary routes in place which allow the MHRA to rely on a decision taken by the EMA when granting an MA for Great Britain.

This is a temporary measure though. The so-called European Commission Decision Reliance Procedure (ECDRP) will expire on 31 December 2023.

Since the departure of the UK from the European Union, fewer new medicines have been authorised in the UK than in the EU and the United States. According to industry experts quoted in the Financial Times, the smaller size of the UK market combined with the “complexity of dealing with the NHS” (as the primary purchaser, it is fragmented and has to navigate complex procurement rules) might keep international drug companies from completing a complex MA application with the MHRA. Recognition routes which rely on approvals from other countries and allow for streamlined applications with the MHRA will lower the entry barriers for new medicines into Great Britain.

The MHRA already collaborates with foreign regulatory agencies, including through schemes such as the Access Consortium and Project Orbis, to ensure patients have timely access to high quality, safe and effective therapeutic products. Those existing partnerships with regulatory agencies provide a basis for the announced international recognition routes. 

Purpose 

The MHRA says the new recognition route is “focused on providing UK patients faster access to the absolute best, most cutting-edge, and safest medical treatments”.

Therefore, it has decided to implement a dual approach for granting MAs for medicines in Great Britain:

  • MHRA’s own assessment and approval procedure; and
  • International recognition routes which allow the MHRA to rely on approvals from trusted regulatory partners around the globe.

In both scenarios, the MHRA will remain responsible for the granting of an MA for Great Britain and it reserves the right to reject applications even if the drug has been approved by a regulatory partner “if the evidence provided is considered insufficiently robust”.

Outlook

The new international framework is due to be in place by the first quarter of 2024 and will clarify the details of the application and assessment procedure of the international recognition routes.

The MHRA is looking into establishing similar routes for medical devices as part of a consultation on recognising conformity assessments or approvals from international regulatory partners.

If you would like to discuss the issues discussed in this post, please contact our Healthcare Team.