New MHRA-NICE Aligned Pathway Launches April 1, Cutting Medicine Approval Time by 3-6 Months
Summary
The MHRA and NICE are launching an aligned approval pathway on 1 April 2026 that synchronises medicine licensing and value assessment decisions, enabling patients in England to access some new medicines three to six months sooner. Twenty-seven pharmaceutical companies registered as early adopters in October 2025, with the first treatments currently going through the pathway and initial guidance expected in June 2026. Alongside the pathway, both organisations are launching an improved Integrated Scientific Advice service offering a single-entry point, aligned meeting and report structure, and unified payment to help companies clarify regulatory requirements early in development.
“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).”
Pharmaceutical companies developing medicines for the UK market should review their regulatory timelines against the new MHRA-NICE aligned pathway. Companies not yet registered as early adopters can still access the pathway through the webinar on 25 March 2026 or subsequent applications, but should consider engaging Integrated Scientific Advice early to clarify data requirements before formal submission and reduce the risk of unforeseen delays in the compressed approval timeline.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA and NICE have jointly established an aligned pathway that merges their respective approval workflows, allowing licensing decisions and value assessments to proceed simultaneously rather than sequentially. The Integrated Scientific Advice service provides a single entry point for companies seeking regulatory guidance, with one meeting structure, one report, and one payment, aligning data and scientific expectations across both agencies. Pharmaceutical companies planning UK market launches should note that early engagement with the Integrated Scientific Advice service can clarify evidence requirements and reduce development delays before formal pathway submission. The aligned pathway does not alter substantive approval standards—medicines must still demonstrate acceptable safety and efficacy—but compresses the overall timeline from development to patient access by up to six months.
Webinar
- Date
- 2026-03-25 at 14:00 – 15:00
- Location
- Virtual
Archived snapshot
Mar 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process
New pathway set to synchronise licensing and value assessment decisions
From: Medicines and Healthcare products Regulatory Agency Published 17 March 2026
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.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Share this page
The following links open in a new tab
Updates to this page
Published 17 March 2026
Mentioned entities
Related changes
Get daily alerts for MHRA Guidance & Safety
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from MHRA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when MHRA Guidance & Safety publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.