The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) will make their respective decisions on new drugs at the same time as part of an overhaul to medicine regulation in the country.
An aligned pathway is being established that will see NICE bring forward its decision for NHS recommendations alongside the MHRA’s licensing verdict. The hope is that the new framework, which launches on 1 April, will bring medicines to patients three to six months sooner and provide companies with a better platform for commercial planning.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Currently, there’s a 90-day gap between MHRA issuing a marketing authorisation and NICE publishing its guidance on cost-effectiveness. Single Technology Appraisals (STA), NICE’s process for evaluating a new treatment, generally takes around 38 weeks.
Lawrence Tallon, MHRA’s CEO, 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.”
In October 2025, the two health agencies initiated a pilot of the new scheme, inviting pharmaceutical companies to register as early adopters. A total of 27 companies signed up, and the first treatments are currently going through the aligned pathway. The first guidance is expected in June 2026.
Alongside the pathway, NICE and the MHRA are also launching an improved Integrated Scientific Advice service, in which evidence requirements for market authorisation and health technology assessment are relayed through a single channel. This can help pharma companies with early planning of clinical development, such as the use of specific endpoints.
Commenting on the new provisions, Professor Jonathan Benger, chief executive of NICE, said: “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.”
A 2025 report from the European Federation of Pharmaceutical Industries and Associations (EFPIA) revealed that England lay sixth when ranked for the availability of new medicines licensed in 2020-2023.
The UK Government has recognised that the country’s life sciences sector is not reaching its full potential. In its Life Sciences sector plan, ministers outlined plans for streamlining regulation and enhancing market access, one of six priority strategies. The alignment between the MHRA and NICE is one of the first major steps taken as part of the revamp.
The six-point action plan is to ensure the UK life sciences sector reaches its forecasted value increase of £41bn, representing a growth of 165% by 2035. The government is aiming to make the UK the leading life sciences economy in Europe, and the third largest in the world behind only America and China.
Dr Zubir Ahmed, minister for health and safety innovation, said: “We’re cutting red tape so safe and effective new medicines can reach NHS patients sooner. 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.”
