On 26 May 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognise decisions to authorise medicinal products taken in other countries so the MHRA can fast track approval in the UK. Further, on 4 July 2023, the MHRA published its Corporate Plan, 2023 to 2026 (Corporate Plan) outlining its four strategic priorities over the next three years, including to “deliver scientific and regulatory excellence through strategic partnerships” through, for example, collaboration with international regulatory partners.
The new international recognition routes will enable recognition of medicinal product approvals in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
The aim is for these routes to be in place by the first quarter of 2024.
New International Recognition Routes
In line with the responses to the consultation on the regulation of medical devices and the recent response to the consultation on the clinical trials regime in the UK, the UK is looking beyond the EU and seeking to align with regulatory regimes around the world in order to secure high-quality and safe medicines for UK patients.
The new international recognition routes will allow the MHRA to take into account decisions taken by trusted regulatory partners in order to streamline the UK assessment process for specific medicinal products. The aim is to provide UK patients with faster access to treatments, and provide an opportunity for increased efficiency and productivity, with less reliance on funding from the Department of Health and Social Care.
The details are not yet known, but we understand that under the plans, the MHRA will remain responsible for approving all ‘recognition route’ applications under the new framework. The MHRA still intends to carry out a rigorous review of applications and will have discretion to reject applications if the evidence provided is considered insufficient. This will ensure that all products are safe and of sufficient quality for authorisation in the UK. These routes will also sit alongside the MHRA’s innovation pathway for medicines, which integrates early regulatory advice with health technology assessment advice (known as the Innovative Licensing and Access Pathway (ILAP)).
The Corporate Plan notes the importance, following Brexit, of working in partnership with other international regulators through these international collaborations to speed up the approval of innovative medicines. The creation of these routes will complement existing international partnerships such as those via the Access consortium and Project Orbis. Similarly, following Brexit, the MHRA introduced temporary routes to market whereby the MHRA could take into account opinions and decisions from the European Commission and national competent authorities in the EU as part of its decision-making process. However, these are due to expire at the end of 2023. The new routes will seek to replace these reliance routes.
At this stage, these are simply policy announcements, and we are aware that the MHRA is speaking to industry bodies to seek views on such recognition. We expect the MHRA and UK Government to publish legislative proposal to implement these initiatives in the future.
Although these new international recognition routes are for medicines, the MHRA intends to launch a consultation on similar recognition routes for medical devices in the autumn, which will consider, for example, recognising conformity assessments conducted by international regulatory partners.