MHRA and NICE collaboration: A new era for accelerating patient access to medicines

This initiative aligns with the NHS 10 Year Health Plan for England and the Life Sciences Sector Plan, which were published this year.  In particular, the UK government was looking for the UK's life sciences regulator to be faster, more agile and pro-innovation to drive economic growth, and faster access to cutting-edge treatments, reinforcing the UK’s global leadership in life sciences and healthcare. The MHRA and NICE provided more details at an online event recently. 

A Strategic Approach to better healthcare regulation

The collaboration’s primary objective is to reduce the time required for NHS patients to access new medicines by three to six months - for the benefit of patients, the NHS and industry. This will be achieved by aligning MHRA and NICE processes to allow for the simultaneous assessment of MHRA regulatory and NICE health technology assessment decisions. By working collaboratively and in parallel, the two organisations aim to streamline processes, minimise delays, and create a more predictable and efficient route to market for pharmaceutical suppliers.

Early and transparent engagement with the industry is a cornerstone of this initiative, providing pharma with the opportunity to opt into a streamlined process that offers clarity, confidence, and a smoother user experience. The parallel process is not compulsory, but optional. 
Key features of the aligned pathway include a single entry point on the government’s website at www.gov.uk for integrated advice, a single integrated advice report and payment process to eliminate unnecessary complexity and a commitment to maintaining the independence of MHRA and NICE, with both having separate roles still - the MHRA focusing on efficacy, safety, and quality; and NICE on cost-effectiveness.

PharmaScan remains the primary source for pipeline data.

 
The MHRA and NICE will not only work with each other, but also others such as the Scottish Medicines Consortium. 
 

Engagement and Next Steps

The full launch of the aligned pathway is anticipated in April 2026. Until then, the MHRA and NICE are seeking feedback from stakeholders to refine and optimise the process. Industry input has already highlighted the importance of transparency, clear guidance, and early engagement. These factors will be critical to the initiative’s success.

VWV's 2026 Pharmaceutical Industry Network Group (PING) Conference will look at the UK's bold Life Sciences Sector Plan and how it will lead Europe by 2030. The Life Sciences Sector Plan has a few key themes, including regulatory reform - streamlining regulation and market access, by supporting the MHRA to be a faster, more agile regulator and giving industry a clearer route to market including through joint advice and parallel approvals with NICE.

For more information or advice, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team (with thanks to Ceri Silva for her input into this article).