UK to accelerate patient access to medicines under new MHRA–NICE joint approach 

Patients in England could receive new medicines up to 6 months earlier under a coordinated regulatory and health technology assessment (HTA) process announced by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) as part of the government’s 10-Year Health Plan. 

The two organizations have set out plans to streamline regulatory and value assessment processes, aiming to accelerate access to innovative treatments for NHS patients. The joint initiative, part of the government’s industrial strategy, is also intended to cut administrative costs for businesses by 25%.  

Health and Social Care Secretary Wes Streeting said the reform is designed to “slash red tape” and position the UK at the forefront of life sciences innovation.  

“By having two of our most important regulators join forces we’ll rapidly remove barriers, get patients access to vital medicines, and grow the economy,” he said. 

Under a new joint information sharing agreement, pharmaceutical companies will be invited to register early with both agencies, enabling parallel decision-making on licensing and value assessment. This approach is intended to ensure more medicines are approved for NHS use at the same time as they are licensed in the UK. Government estimates suggest patients could benefit from earlier access by 3–6 months. 

MHRA Chief Executive Lawrence Tallon highlighted the benefits of closer collaboration with NICE to create “a faster and more efficient regulatory system, designed to accelerate UK market entry and deliver innovative, life-changing treatments to NHS patients faster.” He added that the change would: 

“strengthen the UK’s global life sciences offer and reinforce our position as an attractive destination for innovation and international investment.”  

The coordinated service will provide developers with integrated advice, an aligned pathway for regulatory and HTA requirements, and a clearer route to market. To take part, companies must register their products on UK PharmaScan, the national horizon scanning database, at least three years before the expected marketing authorization. 

Dr Sam Roberts, NICE Chief Executive, noted that the agency has already reduced the average time between licensing and guidance publication by 26% in the year to March. “When companies work with us to reduce timelines NICE guidance is published on average just 48 days after licence,” she said, adding:  

“This joint working with our partners at the MHRA will allow us to accelerate medicines into the NHS even further to help transform the health of the nation, alleviate pressure on the service where possible and support a thriving life sciences sector in this country.”  

Industry bodies also welcomed the move. Mark Samuels, Chief Executive of Medicines UK, highlighted the benefits for earlier launches of biosimilars, “which means more patients can be treated sooner.” Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, said:  

“Streamlining approval processes will allow both agencies to give patients earlier and equitable access to the innovative medicines needed to improve UK health outcomes.”