Patients to receive new medicines up to six months sooner under streamlined MHRA-NICE approval process

Patients in England will be able to access some new medicines three to six months earlier than previously possible, following the launch of a streamlined joint approval process by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE).

The aligned pathway, set to go live on 1 April, will synchronise NICE's decision-making process with the MHRA's licensing procedure, meaning that decisions on both safety licensing and value assessment will be made simultaneously rather than sequentially. The initiative was announced at the NICE Conference in Manchester on Tuesday 17 March by the chief executives of both organisations.

Alongside the new pathway, NICE and the MHRA are launching an improved Integrated Scientific Advice service, offering pharmaceutical companies a single entry point, a single meeting and report, and one payment. The service is designed to clarify regulatory requirements and the evidence needed early in a medicine's development, helping companies refine their clinical development plans and avoid unforeseen delays.

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."

He added that the reforms would give companies "clearer, quicker decisions", helping to make the UK a more attractive destination for life sciences investment.

Early adopters already on board

Pharmaceutical companies were invited to register as early adopters in October 2025, and 27 have since signed up. The first treatments are already progressing through the aligned pathway, with the earliest guidance expected in June 2026.

Professor Jonathan Benger, Chief Executive of NICE, said the new services would give companies "predictable timelines to support effective planning" and help "remove unnecessary delays". He added: "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, described the development as being "about health and prosperity", noting that a streamlined regulatory system would not only benefit patients through earlier access to innovative medicines but also boost research and development investment by making the UK a more attractive launch market for the global life sciences industry.

The initiative follows commitments set out in the government's 10 Year Health Plan for England and the Life Sciences Sector Plan, both of which called for NICE and the MHRA to collaborate more closely. The two organisations have indicated that further joint projects are under way to align processes across medicines and medical devices regulation throughout the UK health and care system.