The Medicines and Healthcare products Regulatory Agency has used its Results and Forecast 2025/26; 2026/27 to argue that faster access to medicines and medical devices can be combined with statutory compliance and tighter safety controls. Published on 28 April 2026, the document says the regulator met or exceeded all statutory targets in 2025/26 and will now carry that approach into a new five-year strategy due later in 2026, covering the period to 2030. (gov.uk) The April publication is a corporate report rather than the full annual account. GOV.UK states that detailed performance and financial information will instead appear in the MHRA’s Annual Report and Accounts, which is due to be presented to Parliament in summer 2026. That matters because the current document is a high-level statement of direction, but it still sets out the policy choices the agency wants attached to its recent performance. (gov.uk)
On safety, the MHRA says it tackled health misinformation, introduced stronger post-market surveillance rules for medical devices, modernised vigilance systems and removed nearly 28 million unauthorised medicine doses from circulation. The same report says the agency met every statutory commitment across licensing, clinical trials and safety decisions, and finished the year in financial surplus. (gov.uk) The report also records improved sentiment among external stakeholders over the previous 12 to 18 months, alongside higher staff engagement and record participation in the staff survey. Those are not patient outcomes in themselves, but they do matter for regulatory delivery because review timetables, enforcement work and post-market monitoring depend on workforce stability and operational capacity. (gov.uk)
One of the clearest practical reforms is the MHRA-NICE aligned pathway, published on 1 April 2026. Under that guidance, NICE technology appraisal guidance can be issued at the same time as MHRA marketing authorisation, with the official aim of getting new medicines to patients three to six months sooner. The two organisations remain independent, but the timetable is designed to remove the delay that can arise when licensing and value assessment happen one after the other. (gov.uk) For companies, the route is optional but potentially important. NICE says participation depends on early horizon scanning and aligned submission timetables, with the offer of earlier NHS market access and more predictable scheduling. For patients and the health service, the intended effect is more straightforward: fewer sequential decisions and a quicker route from regulatory approval to routine use where the evidence supports adoption. (gov.uk)
Clinical trials reform has also moved into implementation. In a 27 April 2026 update, GOV.UK said average set-up time for commercial interventional trials had fallen from 169 days to 122 days, while the MHRA-Health Research Authority combined review process was averaging 41 days. From 28 April 2026, Route B for certain lower-risk substantial modifications became a legal part of the new framework. That is the operational backdrop to the Results and Forecast report’s claim of strong on-time performance in clinical trial decisions. (gov.uk) The rare disease work is equally important. In November 2025, the MHRA said it would rewrite the rulebook for rare therapies to deal with small patient populations and difficult evidence generation, while the England Rare Diseases Action Plan 2026 linked that reform to broader work on specialist care, genetic therapies and earlier access. The Department of Health and Social Care’s plan also points to the use of master protocols for ultra-rare conditions, showing how regulatory reform is now being tied to real delivery questions rather than kept as a separate technical exercise. (gov.uk)
Artificial intelligence is being treated in the same way: as a mainstream regulatory file rather than a side issue. The MHRA became the first country participant in the HealthAI Global Regulatory Network on 24 June 2025, and the National Commission into the Regulation of AI in Healthcare was launched on 26 September 2025 to advise on a new UK framework due in 2026. In policy terms, that places AI oversight inside the core health regulation system, alongside medicines and devices regulation. (gov.uk) Official material presents that work as a combination of earlier market access and tighter oversight after deployment. GOV.UK points to AI Airlock, updated guidance and reform work for adaptive and generative AI, with a strong emphasis on real-world monitoring once tools are used in practice. For developers, that suggests the UK is trying to offer clearer testing and approval routes without lowering expectations on evidence or safety. (gov.uk)
International partnerships are now part of the MHRA’s delivery model rather than an adjunct to it. The agency has pointed to the UK-Singapore Regulatory Innovation Corridor launched on 12 December 2025, a strengthened device cooperation arrangement with the US Food and Drug Administration published on 2 April 2026, and the Access Consortium’s 2026 action plan agreed on 30 March 2026. Across those initiatives, the recurring proposition is less duplication for developers and quicker access to safe products across more than one jurisdiction. (gov.uk) The detail is important. The US text raises the possibility of future mutual recognition mechanisms for parts of device approval processes, while the Access Consortium plan focuses on work-sharing, digital information exchange and shorter response times. In each case, the official documents pair efficiency with explicit statements that national requirements for safety, quality and effectiveness will remain in place. (gov.uk)
Ministers have presented the report as evidence that the regulator is supporting NHS priorities, public health and economic growth at the same time. The release also carries supportive comments from NICE, industry bodies, the Health Research Authority and patient advocates, although that endorsement should be read in context because many of those organisations also have a direct interest in faster and clearer approval routes. (gov.uk) For Policy Wire readers, the more useful reading is beneath the headline claim of targets met. The April 2026 report brings together quicker access timetables, stronger post-market controls, trials reform, AI governance and cross-border cooperation in a single account, with a five-year MHRA strategy still to come later in 2026. The next test will be whether that strategy, and the full Annual Report and Accounts in summer 2026, show that the agency can keep combining speed, safety and predictability once the underlying figures are set out in full. (gov.uk)