The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced a new ‘aligned pathway’ to synchronise licensing and get medicines to patients sooner. This follows commitments in the Government’s ‘10 Year Health Plan for England’ and ‘Life Sciences Sector Plan’, aiming to ensure new medicines are brought to patients ‘3 – 6 months sooner’.[1]
Brevia’s insight on the new approval pathway can be found below. If you require more detailed insight on regulatory approval processes and how the launch will impact your organisation, please contact Brevia Health (+44 (0)20 7091 1655 or email contact@breviahealth.com). For a full list of support options, please visit our services page.
How did the medicines approval pathway previously work?
Historically, the medicines approval pathway in the UK followed a two-step process:
- First, the MHRA granted Marketing Authorisation (MA). This process assesses and ensures the product meets UK safety, efficacy and quality standards.
- Next, NICE completed a ‘technology appraisal’, which evaluated the cost-effectiveness of the product and updated NICE guidelines. This requires the NHS to provide and fund the product as a clinical option.
These steps happened sequentially, leading to a 90-day gap between the two stages.
How does the new approval pathway work?
The new MHRA-NICE aligned pathway will now allow submission of dossiers to NICE before the MHRA finalise their decision. This enables MHRA regulatory approval and NICE health technology assessment decisions to be delivered simultaneously, eliminating the 90-day gap and accelerating the final decision.
The new MHRA-NICE approval pathway includes the following steps:
- Step 1: Organisations must register on UK PharmaScan, the national horizon scanning database. This should be done at least three years before the expected date of attaining an MHRA MA.
- Step 2: When NICE selects the relevant topic for review, organisations must confirm their commitment to submit requested information according to their optimal timelines. NICE will then share a timeline coordinated with the expected MA date.
- Step 3: Organisations should then submit dossiers to the MHRA and NICE via the joint pathway. It is recommended to submit to NICE around 7 months before your expected MA date, depending on the MHRA route. This may mean submitting to NICE before the MHRA.
- Step 4: Using this joint pathway, NICE will schedule the appraisal process to ensure the final decision can be published to coincide with the MA being granted.
What are the benefits of the new pathway?
Pharmaceutical companies using the aligned pathway can benefit from:[2]
- Earlier NHS market access – NICE technology appraisal guidance will be published at the same time as the MA.
- Predictable timelines – priority scheduling from NICE and coordinated milestones to support forward-planning.
- Commercial benefits are realised sooner due to earlier entry into the NHS and longer exclusivity before Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) rebates apply.
- NHS and global markets will be notified earlier. While the aligned pathway is one part of a broader ecosystem, the goal is that over time, it will contribute to speeding up NHS adoption of new medicines.
Do organisations have to use the new pathway?
Using the aligned pathway is optional. Both the MHRA and NICE remain independent and can be engaged individually and operate under separate evaluation standards.[3]
What are the next steps?
NICE maintains that the new process will be evaluated continuously with a particular focus on where same-time publication is not achieved and how this can be improved.[4]
In October 2025, 27 pharmaceutical companies signed up as early adopters of the new pathway. The first treatments are currently going through the aligned pathway with the first guidance expected later this year.[5]
What are stakeholders saying?
The launch of the new pathway has received positive feedback from stakeholders across the healthcare sector:
Dr Zubir Ahmed MP, Health Innovation and Safety Minister said:
“…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.”[6]
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.”[7]
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.”[8]
Support from Brevia Health
If you require more detailed insight on the work of the 10 Year Health Plan, please contact Brevia Health (+44 (0)20 7091 1655 or email contact@breviahealth.com). Further information on our three key service offerings can be found at: public affairs, public relations and market access.
[1] MHRA and NICE, ‘Patients will receive medicines 3-6 months faster under 10-Year Health Plan, as regulators set out plans’, 6 August 2025, Link
[2] MHRA, ‘Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway’, 9 April 2026, Link
[3] MHRA, ‘Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway’, 9 April 2026, Link
[4] NICE, ‘MHRA-NICE pathway opens for business – everything you need to know to get started’, 1 April 2026, Link
[5] MHRA, ‘Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process’, 17 March 2026, Link
[6] MHRA, ‘Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process’, 17 March 2026, Link
[7] MHRA, ‘Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process’, 17 March 2026, Link
[8] MHRA, ‘Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process’, 17 March 2026, Link
