The Medicines and Healthcare products Regulatory Agency (MHRA) has announced measures to highlight the risks of dependence and addiction associated with medicines commonly prescribed for pain, anxiety and insomnia. The changes apply to medicines including gabapentinoids, benzodiazepines and Z-drugs, which will now carry a warning on packaging stating: ‘May cause addiction, dependence and withdrawal reactions.’ Patient information leaflets will also be updated to provide clearer information on dependence and addiction, guidance on tapering treatment, and information to support communication between patients and healthcare professionals during treatment. The Commission on Human Medicines (CHM) supported the development of patient-facing resources highlighting key safety messages, including warnings not to use the medicines with opioids or alcohol and not to share medication with others.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that, together with the National Institute for Health and Care Excellence (NICE), it has secured £2m in funding from Wellcome to continue joint work on the regulation and evaluation of digital mental health technologies until Autumn 2028. Launched in 2023, the programme seeks to establish clearer, risk-proportionate regulatory frameworks for the sector.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the appointment of Professor Jacob George as its first Chief Medical and Scientific Officer, effective 5 January 2026. In this newly established role, Professor George will lead the MHRA's Science Campus in Hertfordshire and oversee the agency's science and innovation strategies, including supporting the development of UK life sciences regulation.

The Medicines and Healthcare products Regulatory Agency (MHRA) has formally assumed the role of chair of the Access Consortium for 2026, succeeding Swissmedic, which held the position in 2025. The Access Consortium brings together regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland to streamline regulatory processes, support innovation and improve global public health outcomes. The Chief Executive of the MHRA, Lawrence Tallon, stated that the consortium’s work in 2026 will focus on delivering its GROWTH manifesto and building on existing foundations to benefit patients and industry across the partner countries and the wider global community.

The Medicines and Healthcare products Regulatory Agency (MHRA) has decided to close its RegulatoryConnect program after assessing how much it will cost to complete the system. MHRA proposed RegulatoryConnect last year as a way to make it easier for industry to see and track their regulatory assessments when it shared guidance on the project. MHRA envisaged users signing into the portal to track the progress of applications and see live license details with plans to add the ability to file applications and variations through the service later. 'The functionality to track applications and view live authorisation details through the existing portal will remain available,' but 'the program no longer offers value for money for UK taxpayers' according to MHRA. MHRA is planning a replacement that aligns with the strategy it intends to publish next year.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the government will continue to accept CE marked medical devices and in vitro diagnostic devices (IVDs) in Great Britain on a long-term basis, following a consultation held from 16 February 2026 to 10 April 2026. The government will not require an additional approval route for devices approved for the EU market. The United Kingdom Conformity Assessed (UKCA) marking route will remain available as the domestic approval pathway, while the MHRA will continue to oversee device safety through existing post-market surveillance and reporting requirements.

The Medicines and Healthcare products Regulatory Agency (MHRA) published the final outcome of its medical devices consultation. The government will proceed with three key reforms: implementing an international reliance framework, removing the UKCA marking requirement, and updating the classification of in vitro diagnostic (IVD) devices. These reforms aim to modernise regulation while supporting innovation and patient safety.

techUK has opened a call for evidence to inform its response to the MHRA consultation on the regulation of artificial intelligence (AI) in healthcare which will close on 2 February 2026. This consultation seeks evidence to inform recommendations for a new regulatory framework for AI technologies within medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA), as a member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), has launched a UK consultation on the ICH M14 Guideline on the use of real-world data for safety assessments of medicines. The M14 'Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines' provides internationally harmonised guidance and outlines recommendations and high-level best practices for the conduct and analysis of non-interventional pharmacoepidemiological studies using fit-for-purpose data for the assessment of the safety of medicines (drugs, vaccines, and other biological products). It aims to streamline the development and regulatory assessment of study protocols and reports, and improve their ability to be accepted across health authorities. This UK consultation is launched in parallel with the European public consultation, which runs until 31 August 2024, and the global public consultation launched by ICH. The consultation closes on 30 October 2024.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported significant progress in combating the illegal trade of medicines in the UK. In 2024, the agency's Criminal Enforcement Unit (CEU) denied criminals access to £7.5 million in assets related to illicit pharmaceutical activities. The MHRA, in collaboration with law enforcement partners, seized over 17 million doses of illegally traded medicines, valued at £40 million. The CEU's powers include freezing bank accounts, intercepting digital currencies, and confiscating proceeds of crime. Working alongside the Home Office's Border Force, the MHRA targeted illegal imports and disrupted over 1,500 websites and social media accounts selling unlicensed medicinal products. Recovered funds will be reinvested to bolster future enforcement efforts against pharmaceutical crime.

The Medicines and Healthcare products Regulatory Agency (MHRA) has been designated a WHO-Listed Authority (WLA) by the World Health Organization (WHO), placing it among 39 regulatory bodies recognised for meeting WHO international standards for medical product regulation. The designation supports the government’s Life Sciences Sector Plan to position the UK as a global hub for innovation and advances the 10-Year Health Plan for England, which sets out a transformative agenda for the NHS. MHRA now joins Health Canada and Japan’s Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) as newly appointed WLAs, strengthening a growing international network of authorities whose work underpins faster, broader access to quality-assured medical products—particularly in low- and middle-income countries. MHRA Chief Executive, Lawrence Tallon, described the designation as a reflection of the agency’s commitment to regulatory excellence, innovation and global collaboration, and its readiness to support faster access to life-saving treatments worldwide.

The Medicines and Healthcare products Regulatory Agency (MHRA) Criminal Enforcement Unit has raided a warehouse in Northampton, seizing over 2,000 unlicensed retatrutide and tirzepatide injection pens valued at over £250,000, along with tens of thousands of empty pens and manufacturing equipment. The two-day operation, supported by Northamptonshire Police, also recovered £20,000 in cash suspected of being linked to medicines trafficking.