On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA is “focused on providing UK patients faster access to the absolute best, most cutting-edge, and safest medical treatments” by allowing fast-track reliance on authorizations from a number of trusted jurisdictions, not just the EU.
What are the Current Reliance Procedures?
After the UK left the EU, the MHRA introduced EU reliance routes. The routes mean that applicants with a marketing authorization (MA) from the EU can undergo an accelerated 67-day review procedure in the UK to obtain an MA. These routes are available to medicinal products approved under the:
- centralized procedure: the MHRA can rely on a decision by the European Commission to grant a centralized MA and determine whether to grant a Great Britain (GB) MA; and
- mutual recognition or decentralized procedure: the MHRA can also consider an MA granted by an EU/European Economic Area (EEA) Member State to grant either a UK or GB MA.
However, these routes are only temporary. They are due to expire at the end of 2023.
How will the New International Reliance Route work?
In its Spring Budget, the UK Government said it intended to introduce a new international reliance route. It would also provide funding to the MHRA to implement this route (discussed in on previous blog here).
The MHRA’s May announcement sets out its plans for this new route. From Q1 of 2024 the MHRA intends to recognize approvals of medicinal products from:
- the European Union,
- Singapore, and
- the United States.
As for all other MAs granted in the UK, the MHRA will still remain the sovereign regulator and will remain responsible for approving all applications under the recognition route. Therefore, even if another regulator has approved a medicinal product, the MHRA retains the authority to reject an application if it does not consider it sufficiently robust.
The announcement highlights that this route will sit alongside the MHRA’s other routes for approval. This includes the MHRA’s own Innovative Licensing and Access Pathway. The MHRA notes “[t]hrough this new dual approach, we will contribute to the UK’s ambition to be a global science superpower, by making the UK one of the best places in the world to bring life-changing healthcare products to patients safely.”
What are the Benefits?
The MHRA sets out a number of benefits of these new reliance routes. By expanding the reliance route to a number of trusted regulatory partners, the MHRA can leverage their “expertise and decision-making.” Additionally, the reliance routes should mean the MHRA can approve “cutting-edge medicines” more quickly, at a lower cost and with a streamlined regulatory process.
This new route should help to reduce the risk of the UK being left behind if companies focus on launching innovative new products in these other jurisdictions. Arguably, the UK should have greater access to such products if they are launched in other key jurisdictions.
This announcement is not legally binding. The UK Government will have to draft a Bill to introduce this new route. This will then have to be approved by Parliament. Finally, the announcement refers to this as the “start of a new international framework for medicines.” It also notes that work has started on developing similar routes for medical devices. Therefore, we would expect the MHRA to publish details of other expedited routes for medicinal products and medical devices in future.