The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the new process changes for the assessment of established medicines, which will come into force on 1 March 2024. The changes will allow the agency to examine applications efficiently and to ensure smoother and faster approvals process for applicants. The guidance will also assist applicants and reduce timeframes for examination of established medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for medicines following the agreement of the Windsor Framework. The implemented changes include all medicines approved in the UK will be licensed by the MHRA and authorised under the Human Medicines Regulations 2012 (HMR 2012), SI 2012/1916, from 1 January 2025. Requirements for periodic safety update reports, post-authorisation safety studies, and other pharmacovigilance topics will also be implemented on 1 January. The guidance also categorises products into two categories based on their authorisation status under UK requirements. Category 1 covers products authorised in the UK and Category 2 covers products authorised in both the UK and EU. Companies are expected to submit safety reports to both the MHRA and the European Medicines Agency. Safety reports for Category 1 products with UK-only licenses will only be submitted to the MHRA.

The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 3 April 2025 detailing its national assessment procedure for marketing authorisation applications. The guidance introduces separate pathways for innovative and established medicines, with innovative medicines eligible for decisions within 150 days if issues are resolved in one round, while both categories have a maximum timeline of 210 days. The document implements Windsor Framework changes affecting product categorisation and outlines specific submission requirements, assessment phases and consultation procedures with the Commission on Human Medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has released a research report from Woodnewton, on user and public perspectives in digital mental health technology (DMHT). The report's review includes the launch in May 2023 by the MHRA and the National Institute for Health and Care Excellence of a three-year joint work programme, with funding from the Wellcome Trust. The main aim of the project is to provide guidance on appropriate, risk proportionate regulation and consistent evaluation. The report's content also includes a review of participants’ expectations of what forms of regulation are, could be or should be put in place. This includes discussion on who should be responsible for the safety and effectiveness of DMHT, management of risk and safety, the scope for self-regulation and the need for testing, reporting and guidance for users.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the guidance on the Implementation of the Future Regulations with a roadmap that highlights the intended timelines for delivering the future core regulatory framework for medical devices. The regulations will be delivered through four Statutory Instruments. It is expected that priority measures to improve post-market surveillance will be in place in 2024, and the essential parts of the new framework will be in place in 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported a 17% increase in approved clinical investigations in 2025 compared to 2024, reaching record levels. The agency has maintained 100% compliance with statutory deadlines for clinical investigation applications since September 2023, with average approval times of 51 days in 2025, nine days faster than the 60-day target. From January 2026, the MHRA has implemented a fee waiver pilot scheme for micro and small UK firms to reduce barriers for early-stage companies. The agency has also announced a package of measures to support innovation, including enhanced support for high-impact technologies and early market access for promising devices. Neurotechnology studies have doubled since 2024, comprising approximately 25% of all UK applications, while AI-powered medical device studies have also increased. The MHRA has joined a UK-wide partnership led by Newcastle University to update national guidance on neurotechnology research to streamline the approval process for devices interacting with the brain and nervous system.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported that clinical trial approval times have been reduced from an average of 91 days to 41 days following the implementation of risk-proportionate regulatory reforms and digital platforms introduced in 2023. Research published in the British Journal of Clinical Pharmacology on 6 October 2025 analysed over 4,600 clinical trial applications, finding that 99% of initial applications were completed within the statutory 30-day timeframe. The reforms include a fast-track route enabling lower-risk studies to be approved within 14 days and the deployment of artificial intelligence tools to support regulatory assessments. New legislation taking effect in April 2026 will require all UK clinical trials to publicly register and publish their results, including plain-language summaries for participants. The legislation will also extend the deadline for sponsors to respond to regulator feedback from 14 to 60 days, intended to align with international trial timelines. The MHRA's Combined Review process with the Health Research Authority now runs ethical and regulatory assessments in parallel to reduce duplication for researchers.

The Medicines and Healthcare products Regulatory Agency (MHRA) reports that, through its collaboration with eBay, 215 listings of potentially harmful and unauthorised erectile dysfunction medicines have been removed from the platform. The tablets appeared to be counterfeit, which was confirmed by the MHRA’s Borderline Products team responsible for product classification. The MHRA advises against buying medicines from social media, messaging apps, or unknown websites. Pharmacy and prescription medicines should be obtained from a UK registered pharmacy displaying the green cross and patients should consult a doctor or pharmacist for advice.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported the seizure of approximately 4.4 million doses of unlicensed erectile dysfunction pills in 2025, bringing the total seized between 2021 and 2025 to 19.5 million doses. The seizures were carried out by the MHRA's Criminal Enforcement Unit in collaboration with Border Force to intercept shipments and disrupt organised criminal networks. The pills contained the active ingredients sildenafil, tadalafil, vardenafil and avanafil and were being illegally sold online. Annual seizures have more than doubled since 2022, with erectile dysfunction pills remaining among the most frequently seized illegally traded medicines in the UK. The MHRA has advised the public to avoid purchasing medicines from social media, messaging apps or unknown websites, to use only UK-registered pharmacies displaying the official green cross logo and to consult GPs or pharmacists for safe treatment options.

The Medicines and Healthcare products Regulatory Agency (MHRA) has secured £3.6 million in funding over three years to expand its Artificial Intelligence (AI) Airlock programme, the UK's first regulatory sandbox for AI as a Medical Device (AIaMD). The Department of Health and Social Care (DHSC) will allocate £1.2 million per year from 2026–29. The funding will support longer-term testing models and contribute to the development of a more sustainable regulatory pathway. Phase two examined regulatory challenges, including pre-determined change control plans, AI-powered diagnostic tools and issues relating to scope expansion. Reporting for phase two is expected to be published in summer 2026. Insights from the programme will also inform the National AI Commission’s work on the future regulation of AI in healthcare. This initiative is led by the MHRA in collaboration with the DHSC, the National Health Service AI Team and Team AB (the consortium of UK approved bodies).

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced in a press release that during 2023, it seized more than 15.5 million doses of illegally traded medicines with a street value of more than £30m. This includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical products. The seizure included prescription-only anti-anxiety medicines, opioids, sleeping pills and falsified and unlicensed lifestyle products such as erectile dysfunction and hair loss medications, as well as a small number of aesthetic products such as Botox and semaglutide-containing ‘weight loss’ products. More than 12,000 websites illegally selling medical products were disrupted and almost 3,000 social media profiles were shut down. In 2023, six MHRA investigations resulted in significant custodial sentences for many of those convicted.

The Medicines and Healthcare products Regulatory Agency (MHRA) has selected seven AI healthcare technologies for the second phase of its AI Airlock regulatory sandbox programme, scheduled to run until March 2026. These technologies include AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems. They address three key regulatory challenge areas: the scope of intended use extension and validation, AI-powered in-vitro diagnostic devices, and post-market surveillance with predetermined change control plans.