The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on electrical aspects for clinical investigations to obtain UKCA/CE/CE/UKNI markings for medical devices. The MHRA recommends that a clinical investigation application includes a separate document for electrical safety and electromagnetic disturbances, which is the generic International Electrotechnical Commission term for both Electromagnetic Compatibility and Electromagnetic Interference. The MHRA adds that the guidance is intended to provide basic supporting explanatory advice for devices that are electrically powered but is not prescriptive as devices vary in complexity.

The Medicines and Healthcare products Regulatory Agency (MHRA) and University of Liverpool has published their first comprehensive analysis of 4,616 UK clinical trials from 2019-2023 on 10 April 2025. The study found commercial sponsors conducted 85.1% of trials, with cancer research dominating at 29.4%. The analysis revealed underrepresentation in key areas including heart disease (5.2% of trials), pregnant women (1.1%), and advanced therapy medicinal products (3.4%). MHRA will use these findings to implement new clinical trials regulations aimed at streamlining approvals while maintaining safety standards.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have announced that the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, have come into force. The reforms introduce notifiable trials, providing a fast-track pathway for lower-risk trials to begin more quickly, alongside faster approval processes for modifications and first-in-human trial assessments. They also establish, for the first time, a legal requirement to register clinical trials and publish summary results. In addition, the Route B pathway for substantial modifications, piloted between October 2025 and March 2026, will now be mandatory, enabling eligible modifications to be automatically approved unless concerns are raised within 14 calendar days. The reforms further enhance support for early-stage research, including permitting the use of early safety data from overseas studies that meet UK standards and computer model simulations to help predict how new medicines may perform before clinical testing.

The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) outlined new regulatory processes on 17 March 2025 as part of wider government reforms. From July 2025, MHRA will permit point-of-care manufacturing of personalised medicines, while NICE aims to complete 60% of Technology Appraisals within 240 working days by 2025/26. The regulators will launch an integrated scientific advice service and implement concurrent marketing authorisation and technology appraisal processes to reduce approval times for new medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) are offering designated early access medicines manufacturers access to the aligned streamlined approvals pathway six months earlier than projected. The aligned pathway combines the MHRA’s licensing process and NICE’s value assessment process, meaning decisions will be published at the same time, instead of consecutively. This will reduce the 90-day gap between marketing authorisation and NICE guidance decisions, accelerating patient access and support for the NHS to provide industry with a more efficient route to market. A new fully integrated joint scientific advice service, launching by April 2026, will provide a single-entry point for coordinated advice from the MHRA and NICE to help avoid delays and support alignment. Pharmaceutical companies should register medicinal products on UK PharmaScan at least three years before MA licensing and to engage early with the regulators.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have published guidance on the MHRA–NICE aligned pathway. The pathway is intended to facilitate earlier access to new medicines for National Health Service (NHS) patients by aligning NICE technology appraisal timelines with MHRA marketing authorisation decisions. The pathway is optional and applies across all therapeutic areas. It enables regulatory and health technology assessment decisions to be reached at broadly the same time, while both organisations continue to operate independently and apply their respective evaluation standards. The guidance sets out how companies can join the pathway, including registering medicines on UK PharmaScan at least three years before expected marketing authorisation, confirming commitment to NICE optimal timelines and submitting dossiers to both MHRA and NICE so that aligned decisions are delivered at the same time.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced an aligned pathway to synchronise licensing and value assessment decisions, aimed at enabling patients in England to access new medicines three to six months sooner. Launching on 1 April 2026, the pathway runs NICE and MHRA processes in parallel, alongside a new Integrated Scientific Advice service offering a single-entry point and aligned evidence requirements. The initiative aims to reduce delays, provide companies with clearer timelines and support clinical development planning, with first guidance expected in June 2026. This development forms part of the government’s commitments in the 10 Year Health Plan for England and Life Sciences Sector Plan.

The Medicines and Healthcare products Regulatory Agency (MHRA) and Regulatory Innovation Office (RIO) have opened a call for evidence on the use of artificial intelligence (AI) in medicines development and safety evaluation. The call seeks information from organisations on how they are using, developing or planning to use AI-based approaches, as well as barriers and challenges relating to model development and validation, data access and sharing and regulatory considerations. The findings will inform the development of the ‘Beyond ADMET: AI for medicines safety’ regulatory sandbox announced in June 2026, which will explore the use of AI in assessing the absorption, distribution, metabolism, excretion and toxicity (ADMET) of medicines. The proposed sandbox will use iterative workshops to provide a structured regulatory environment in which developers can test, demonstrate and refine AI-based predictive tools intended for use in medicines development and regulatory submissions. The MHRA and RIO are seeking views from organisations across the medicines development pathway, including those involved in toxicology, preclinical and clinical research and testing, life sciences, biotechnology and AI. Respondents do not need to be currently using AI-based approaches and may provide information on future plans and areas of unmet need. The call for evidence closes on 22 December 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the publication of a scientometric analysis in the European Journal of Epidemiology demonstrating the global impact of its Clinical Practice Research Datalink (CPRD). The CPRD is a not-for-profit research service that provides anonymised data from GP Practice across the UK. Conducted by researchers at the University of Oxford and the MHRA CPRD team, the study identifies several key findings: (1) 3,779 peer‑reviewed publications used CPRD data between 1988 and 2024; (2) research output has increased at an average annual rate of 16.37%; (3) researchers from 29 countries, led by the UK, the US and Canada, have drawn on the dataset and (4) over 80% of recent studies have used CPRD primary care data linked with hospital, mortality or other health datasets.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications for an expanded AI Airlock programme following last year's pilot. The agency has also become the first founding member of Health AI's new global network of health regulators, aimed at sharing early warnings on safety and shaping international standards. Additionally, MHRA's Centre of Excellence for Regulatory Science and Innovation (CERSI) partner RADIANT has launched an Innovator Support Programme, while the agency prepares to publish Good Machine Learning Practice guidance to align with international principles. These initiatives form part of MHRA's strategy to balance innovation with patient safety in AI medical devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new project aimed at predicting side effects from drug combinations before they reach patients. The initiative is supported by £859,650 in funding from the UK Government’s Regulatory Innovation Office through its AI Capability Fund. The project will apply AI to anonymised NHS data to identify patterns in how cardiovascular medicines interact when prescribed together. These signals will be validated in laboratory settings using human-based models that simulate drug metabolism. The MHRA states that the goal is to develop a tool that supports safer and more effective prescribing practices.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that regulatory authorities from Australia, Canada, Singapore, Switzerland and the UK have agreed 2026 priorities at a meeting held on 30 March to strengthen collaboration and improve regulatory efficiency. The agencies endorsed a 2026 action plan aligned with the GROWTH manifesto, focusing on enhanced work-sharing processes, the development of a shared secure digital platform to support joint regulatory activity, and reducing response times for applications submitted through the Access pathway to enable faster access to safe, effective and high-quality medicines. Key initiatives agreed include establishing a regulatory reliance approach for clinical trials and a new network for scientists involved in batch testing. They also agreed to adopt a more coordinated approach to communications and stakeholder engagement while maintaining national regulatory responsibilities.