The Medicines and Healthcare products Regulatory Agency (MHRA) announced its pilot programme offering clinical investigation application fee waivers to micro and small UK enterprises developing innovative medical devices. The programme, running from 4 January 2026 to 31 March 2026, provides ten waivers for Class I, IIa, or Class IIb applications. Eligible devices must be new or represent novel modifications with no existing UK-approved solution for the same clinical need, and they must demonstrate scalability potential. To qualify, applicants must obtain MHRA small enterprise status and include specific documentation in their cover letter that confirms their eligibility and explains how their device meets the innovation criteria.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot scheme for Route B substantial modifications to clinical trials, following the approval of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 which comes into effect on 28 April 2026. This initiative enables automatic approval of eligible modifications within 14 days, replacing the previous 35-day timeframe, and will become mandatory under the new regulations. The pilot is open to industry, academic and NHS sponsors, with over 40 organisations already registered and will run from 1 October 2025 to 31 March 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its Data Strategy for 2024–2027, aiming to leverage data and digital technologies across the medical product lifecycle. The strategy highlights five core themes, including data-driven innovation, Real-World Evidence (RWE)-based regulatory decisions, and the ethical use of AI. In alignment with these goals, MHRA has announced a UK RWE scientific dialogue pilot program, which will open for applications of interest from 10 February to 4 April.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a refreshed UK-wide Innovative Licensing and Access Pathway (ILAP). This initiative, developed in collaboration with Health Technology Appraisal Bodies and the National Health Service (NHS), aims to streamline the process for bringing transformative medicines to NHS patients. The updated ILAP offers improvements such as NHS involvement as a core partner, more selective entry criteria, and predictable timelines. Open to both commercial and non-commercial developers from March 2025, the pathway requires applicants to submit medicines that have not yet entered confirmatory trials, potentially accelerating access to innovative treatments within the NHS.

The Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore’s Health Sciences Authority (HSA) have established a Regulatory Innovation Corridor to accelerate patient access to breakthrough health technologies. This initiative allows companies to engage with both regulators simultaneously, obtain early joint advice, and streamline clinical trial design to reduce duplication and delays. The collaboration targets high-impact areas such as cancer, neurodegenerative diseases, obesity, rare conditions, and advanced diagnostics, while maintaining rigorous safety standards. Flagship Pioneering will be the first company to access the corridor, providing regulators early insight into its portfolio of next-generation genetic medicines, precision immunology, and digital health solutions.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a stakeholder survey seeking evidence from Great Britain's health institutions regarding their experience with the health institution exemption for medical devices. The initiative, closing on 15 September 2025, builds on the government's response to the 2021 consultation on medical devices regulation and the Medical Devices Regulatory Reform roadmap. Aligned with the Government's 10-Year Health Plan for England and Life Sciences Sector Plan, the survey aims to refine exemption policy to enable innovative technology delivery closer to communities. Key focus areas include extending access beyond health institutions, strengthening safety through enhanced post-market surveillance, and supporting health service reforms from hospital to community care. The MHRA will use responses to inform future consultations, guidance, and regulatory updates planned for the coming year.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new regulatory sandbox for AI as a Medical Device (AIaMD), the AI Airlock, as a part of a pilot project set out in its strategic approach to AI published in April 2024. The AI Airlock is designed to assist in safe development and deployment of AIaMDs and takes account of evidence-based work produced by other bodies with a similar focus. The findings from this partnership between the government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance. The AI Airlock will initially support four to six virtual or real-world projects through simulation.

The Medicines and Healthcare products Regulatory Agency (MHRA), the Medical Research Council and Office for Life Sciences have launched a £20 million funding opportunity to establish four Centres of Excellence for Regulatory Science and Innovation (CERSIs), each funded for up to five years. The centres will bring together academic, industry, healthcare and regulatory expertise to develop evidence, methods and skills for the safe adoption of healthcare innovations. They will focus on data-driven approaches and artificial intelligence, prevention and early detection, personalised healthcare and pharmacogenomics, and novel platform technologies. The programme builds on a pilot involving seven centres and aims to strengthen regulatory science capability across the UK health and life sciences sector.

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new legislation to reform the UK’s clinical trials framework. The changes include a 30-day review timeline, combined regulatory and ethics reviews, and mandatory trial registration in the World Health Organization public register. The reforms aim to streamline approval processes, enhance transparency, and promote patient diversity, coming into force after a 12-month implementation period.

The Medicines and Healthcare products Regulatory Agency (MHRA) has marked 100 years since the first biological standard was established, announcing that it produces over 95% of the World Health Organization's biological standards. The MHRA supplied over 110,000 vials or ampoules to 1,500 organisations across 81 countries between 10 October 2024 and 30 September 2025, and now provides more than 450 different WHO standards used to develop, test and monitor biological medicines. The agency's British Pharmacopoeia sets legally binding quality standards for medicines used in the NHS. The MHRA stated that biological standards ensure medicines work consistently regardless of where they are manufactured, providing a framework that supports the safe development, testing and use of medicines, vaccines and diagnostic tests globally.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported that it has met all statutory performance targets for the 2025/2026 financial year, while enhancing patient access to medicines and reinforcing the UK’s position as a global life sciences hub through improved regulatory efficiency, innovation and international collaboration. The MHRA reported strong on-time performance across licensing, clinical trials and safety decisions, alongside enhanced patient protection measures, including stronger post-market surveillance, action against health misinformation and the removal of nearly 28 million unauthorised medicine doses. It also highlighted leadership in regulatory science, with investment in artificial intelligence, in-silico research and reforms to clinical trials and rare disease pathways, as well as expanded partnerships with organisations such as the National Institute for Health and Care Excellence and the US Food and Drug Administration, and international initiatives like the UK–Singapore Innovation Corridor. The MHRA ended the year in financial surplus with improved stakeholder confidence and indicated it will build on this progress through a new five-year strategy to support patient safety, NHS priorities and growth in the UK’s £100 billion life sciences sector.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications for AI developers to join its AI Airlock regulatory sandbox. The AI Airlock will help the MHRA identify and address issues with regulating AI medical devices to ensure that innovative and safe AI medical devices can be safely used in a time efficient manner and be beneficial for the NHS and patients. Candidates will gain an enhanced understanding of the regulatory framework with access to bespoke testing plan and will be able to collaborate with industry and regulatory experts. The call for applications will close on 7 October 2024.