A new approach to regulation by the MHRA and NICE

1. In relation to the MHRA, the government has pledged to introduce new regulations from July 2025 that will enable development of personalised and critical medicines to be manufactured and supplied for patients at the point of care, such as in hospitals or at home. This will increase the appeal of the UK for marketing new life-saving medicines. 
2. The focus for NICE lies on its Technology Appraisal process, which evaluates the clinical and cost-effectiveness of new medicines and technologies. The government aims to increase the proportion of Technology Appraisals that are completed within 240 working days after Marketing Authorisation from 40% this year to 60% for appraisals started in 2025/26, hopefully speeding up the availability of new medicines and technologies for patients and the NHS.
3. Finally, the government plans to enhance the collaboration and alignment between MHRA and NICE. Two initiatives are proposed to achieve this: a pilot for concurrent MHRA marketing authorisation and NICE technology appraisal, which will reduce delays to patient access to medicines, and an ‘Integrated Scientific Advice’ service, which will provide a single point of entry for pre-market scientific advice from both regulators.

These pledges demonstrate the government's commitment to creating a more agile, proportionate and innovation-friendly regulatory system for the health and life sciences sector, which is welcomed and vital to the UK's competitiveness in this area. However, they also raise some questions and challenges, such as how the regulators will balance the need for speed and flexibility with the need for robust evidence and scrutiny. We are interested to see how regulators will coordinate and communicate with each other and with stakeholders.