The MHRA and NICE aligned pathway and an improved advice service will help get new medicines to patients faster and support companies to plan with more certainty.
Patients in England are set to receive some new medicines three to six months earlier under a streamlined approval process being launched by the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
This follows commitments in the government’s 10 Year Health Plan for England and Life Sciences Sector Plan for NICE and the MHRA to work together more closely to get medicines to patients sooner.
The aligned pathway, which launches on 1 April, will help to bring NICE’s decision-making process forward to run alongside MHRA’s, resulting in decisions on licencing and value being made at the same time.
Alongside the pathway, NICE and the MHRA are also launching an improved Integrated Scientific Advice service. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.
Integrated Scientific Advice has been designed to help companies follow the aligned pathway timelines by clarifying regulations and the evidence required early in the development process. This will help companies improve their clinical development plans and reduce unforeseen delays.
The launch of both services was announced at the NICE Conference in Manchester today (Tuesday, 17 March) by Professor Jonathan Benger, Chief Executive of NICE, and Lawrence Tallon, Chief Executive of the MHRA.
This joint work does not end here, with more ongoing projects between the two organisations all helping to align processes and achieve efficiencies for medicines and medical devices across the UK health and care system.
Pharmaceutical companies can join a webinar at 2-3pm GMT on Wednesday, 25 March to find out more about the aligned pathway and integrated scientific advice service and how and when to apply.
Dr Zubir Ahmed, Health Innovation and Safety Minister, said
As a practising surgeon, I know how important it is that patients get access to the latest treatments as quickly as possible.
That’s why we’re cutting red tape so safe and effective new medicines can reach NHS patients up to six months sooner and get patients back to full health earlier.
Not only that, but this will also give companies clearer, quicker decisions – helping make the UK an even more attractive place to invest in life sciences and bring innovations to market, boosting the economy in the process.
Professor Jonathan Benger, Chief Executive of NICE, said
The services announced today will help to bring safe, effective medicines to patients faster by aligning licencing and value assessment decisions. They will give companies predictable timelines to support effective planning, tell them what evidence is required earlier in the process and help to remove unnecessary delays.
By working more closely with our partners at the MHRA, we can get medicines into the NHS faster, helping to improve peoples’ health, ease pressure on NHS services and support a strong life sciences industry in this country.
Lawrence Tallon, Chief Executive of the MHRA, said
This development with our partners at NICE is about health and prosperity. A streamlined regulatory system is better for patients as it means earlier access to innovative medicines by up to six months. Our continued collaboration also makes the UK an even more attractive launch market for the global life sciences industry so will boost R&D investment and economic growth in this country.
In October 2025, pharmaceutical companies were invited to register as early adopters. A total of 27 companies signed up, and the first treatments are currently going through the aligned pathway, with the first guidance expected in June 2026.
Notes to Editor
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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