UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
refuses an application upon the advice of CHM, an appeal can be made. The UK is also part of an access consortium work-sharing procedure. This allows for simulta- neous submission to the UK, Australia, Canada, Singapore and/or Switzerland, for an interna- tionally co-ordinated review. The standard pro- cedure takes 180 days (excluding stop-clocks). In addition, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bring- ing innovative medicines and medicine-device combinations to the UK market more quickly. It was first launched in January 2021, and was re- launched in January 2025. Successful applicants are awarded an Innovation Passport, which ena- bles developers to work collaboratively with the national health services (NHS), MHRA, and UK Health Technology Assessment (HTA) bodies to bring products to the UK market in a more streamlined and efficient way. In relation to medical devices, the UK has launched the Innovative Devices Access Path- way (IDAP) pilot that is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK mar- ket. Eight technologies were selected that will receive tailored regulatory and access support. 4.2 Regulatory Reliance On 1 January 2024, an International Recognition Procedure (IRP) for medicinal products came into force in the UK, which enables the MHRA to consider the expertise of regulatory partners in other countries and utilise pre-existing approvals to speed up authorisation in the UK, including (but not limited to) approvals in the EU. Such partners are referred to as reference regulators (or RR). The product must be classified as a
medicinal product in accordance with the HMRs and the IRP application must relate to the same product for which authorisation has already been granted by an RR. The IRP can be used for mul- tiple types of MA applications, including chemi- cal and biological new active substances, known active substances, generics, hybrids, biosimilars and new fixed combination products. There are two recognition routes under the IRP: Recognition A (60 day timetable) and Recog- nition B (110 day timetable), to which different eligibility criteria apply. The main criteria for Rec- ognition A are that the RR approval was granted within the previous two years and manufacturing processes are the same, with evidence of GMP compliance. For Recognition B, possible appli- cable criteria are more numerous, but the main criterion is that the RR approval has been granted in the previous ten years, subject to exceptional circumstances. While MHRA will conduct a tar- geted assessment of IRP applications based on the assessment by the RR, it may reject applica- tions on the basis that evidence supplied by the applicant is not sufficiently robust. For medical devices, as discussed above, EU CE marks are recognised in Great Britain until 30 June 2030 at the latest depending upon the type of device. The UK Medical Devices Regulations are cur- rently under review and part of the consultation process included considering alternative routes to market. In 2024, the MHRA published a state- ment of policy intent for international recognition of medical devices, which describes MHRA’s intentions for recognition by the UK of interna- tional regulators’ approvals for medical devic- es. It is anticipated that comparable regulator countries will be (at least initially) the EU, as well as Australia, Canada and the USA, and various
368 CHAMBERS.COM
Powered by FlippingBook