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We are writing on behalf of the UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator of medicines, medical devices and blood components for transfusion, and the National Institute for Health and Care Excellence (NICE), the national Health Technology Assessment (HTA) body for England.
The MHRA focuses on driving rapid assessment, innovation, and delivery of safe, high-quality, and efficacious products for the benefit of patients, public health and the Life Sciences sector. NICE helps practitioners and commissioners get the best care to people, fast, while ensuring value for the taxpayer. NICE does this by providing rigorous, independent assessment of evidence for new health technologies and producing useful guidance for the health and care system.
The UK is in a unique position globally, with one national taxpayer-funded healthcare provider – the National Health Service (NHS) – providing healthcare to over 65 million people. As an early launch market, the UK offers a transparent and predictable pathway for market entry, and the NHS (in England) is mandated to fund medicines recommended in NICE guidance. This means that once your medicine is approved as meeting MHRA’s standards for safety, quality and effectiveness, the NHS will make it available to patients within 90 days of a positive NICE recommendation. NICE recommendations are referenced in dozens of other markets too, so the advantages extend beyond the UK.
In March 2025, the UK Government underlined their commitment to improve alignment between MHRA and NICE. This will help to ensure rapid patient access to new medicines by improving alignment between regulatory decisions and publication of HTA guidance through greater information sharing and collaborative working and a refreshed integrated scientific advice service with the MHRA and NICE to support medicines developers. More information will be shared at an online webinar, scheduled for 1 October 2025. Registration details for the event will be published shortly.
As part of this process, we will launch a new approach to collaborative information sharing between the MHRA and NICE. By opting in, you will be consenting to the sharing of procedural information between NICE and the MHRA. This enhanced collaboration means that you will benefit from priority committee scheduling by NICE, with a commitment to publish guidance concurrently with MHRA marketing authorisation (for topics following optimal timelines), reducing the time to gain market access in the UK.
The new collaborative approach enables a NICE appraisal committee meeting and draft guidance consultation (where required) before MHRA approval — streamlining progress through the regulatory and HTA processes.
For some complex topics a NICE appraisal committee meeting and draft guidance consultation before MHRA approval may not be possible, for these the process will revert to alternate scheduling, with NICE committee discussions beginning after marketing authorisation is granted. Please see Annex 1 for a draft process flow. Full guidance on both pathways will be published in due course
If you are intending to launch new medicines in the UK, and want to benefit from our aligned scheduling, UK PharmaScan is your first port of call. Developers must provide timely, accurate, and comprehensive information in UK PharmaScan, with a record created at least 3 years prior to expected Marketing Authorisation. This allows the MHRA and NICE to schedule our work programmes appropriately and avoid delays to patient access in the UK. You should use UK PharmaScan to notify UK agencies of your products’ development status, irrespective of the regulatory route you are intending to take with the MHRA.
If you would like to launch your medicine in the UK, we’d strongly advise registering it on UK PharmaScan and to engage early with both the MHRA and NICE. Failure to do so promptly may delay our ability to produce timely guidance to the NHS, which could impact patients having access to new, effective medicines.
If you have any questions about the UK’s processes, please feel free to reach out to presubmission@mhra.gov.uk, the MHRA’s scientific advice service, or NICE Advice, all of which would be happy to help with further support. The MHRA’s advice service is fees-based, with a waiver available for UK-based SMEs. NICE Advice is also a fee-based advisory service, which offers advice, insight and education services to help you prepare for a NICE evaluation or engagement with the UK market.
Best wishes,
 Julian Beach
Interim Executive Director Healthcare Quality and Access, MHRA
 Helen Knight
Director of Medicines Evaluation, NICE
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