Patients in England will gain access to some new medicines three to six months earlier under a major new streamlined approval process launched jointly by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence.
The new aligned pathway, launching 1st April, is designed to speed up patient access and give life sciences companies greater certainty when planning development and regulatory strategies. It delivers on commitments in the Government’s 10 Year Health Plan for England and the Life Sciences Sector Plan, which set out a shared ambition for MHRA and NICE to work more closely in accelerating innovative treatments to the NHS.
Historically, MHRA licensing and NICE value assessments happened sequentially, often resulting in delays between regulatory approval and NHS access. Under the aligned pathway, NICE will bring its decision‑making forward to run alongside the MHRA’s licensing process.
This means that licensing decisions and value assessments will be completed in parallel, allowing clinicians and patients to benefit from earlier access once a medicine is authorised.
Alongside the aligned pathway, MHRA and NICE are also launching a new Integrated Scientific Advice service to support companies earlier in the development process.
The improved ISA service will provide:
- A single entry point
- Joint meetings and coordinated reports
- One combined fee
- Aligned expectations on data and evidence requirements
This will help companies design stronger clinical development plans, understand regulatory and HTA expectations at the same time, and avoid unnecessary delays caused by misaligned data packages.
The new service is intended to help developers meet aligned pathway timelines more easily, reducing risk and uncertainty and enabling more efficient progression to market.
The launch of both initiatives was announced at the NICE Conference in Manchester by Professor Jonathan Benger, Chief Executive of NICE, and MHRA Chief Executive Lawrence Tallon.
Both leaders emphasised the importance of greater collaboration to streamline processes, support innovation, and strengthen the UK’s position as a global leader in life sciences.
Professor Benger commented:
“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.”
MHRA and NICE confirmed that these initiatives form part of a wider programme of ongoing collaboration, with further joint projects already underway to align processes and increase efficiency across the UK health and care system.
This includes work on medical devices, regulatory efficiency, evidence generation and system‑wide improvements that will further support the rapid introduction of safe, effective treatments for NHS patients.
The aligned pathway and improved advice service represent a significant shift toward faster access, clearer guidance for companies, and a more predictable regulatory environment – all supporting the government’s mission to make the UK one of the best places in the world to develop, test and launch new medicines.
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