The Medicines and Healthcare products Regulatory Agency (MHRA) has published a report presenting findings from its research which explored how current and potential users of digital mental health technologies (DMHT) and intermediaries understood the potential for harm posed by DMHT, how they might recognise harm to themselves or others and how they could be encouraged and facilitated to report it via the MHRA Yellow Card Scheme. The study found that although many participants had experience with mental health apps, few recognised the term DMHT or perceived significant risks, though some concerns were raised about excessive screen time, financial exclusion, use of AI, self-treatment, misdiagnosis and addiction. Awareness of the Yellow Card scheme was low, and most users were unlikely to report harms unless guided by healthcare professionals. Participants supported embedding simple reporting tools within apps and increasing awareness through NHS channels.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance to support the implementation of the UK’s decentralised manufacture (DM) framework, which encompasses both point of care (POC) and modular manufacturing (MM). These manufacturing modes enable medicines to be produced near or at the patient’s location and are underpinned by a statutory ‘hub and spoke’ model, where a central Control Site oversees compliance and production activities across distributed sites. The DM framework, introduced through Statutory Instrument 2025 No. 87, amends existing human medicines and clinical trials legislation to reflect the operational differences and regulatory challenges posed by decentralised techniques, including the need for consistent product quality across novel and geographically dispersed sites.

The Medicines and Healthcare products Regulatory Authority (MHRA) has published a study involving 23 laboratories from 11 countries, revealing significant variability in global microbiome research methods. The study tested identical samples using World Health Organization International Reference Reagents, which contain DNA from known bacterial compositions. Results showed that species identification accuracy ranged from 63% to 100% across different methods, false positive rates varied between 0% and 41% and sample diversity estimates differed markedly—from 12 to 185 bacterial species in the same sample. Based on these findings, the research establishes Minimum Quality Criteria for four key reporting measures that laboratories can use to validate their microbiome analysis methods.

MHRA has published two guidance on UK Parallel Import Licences (PLPIs) following the Agreement of the Windsor Framework and on the disapplication of Falsified Medicines Directive (FMD) safety features. Parallel Distribution Notices (PDNs) were replaced by PLPIs through the PDN to PLPI conversion process, which allow the products to be marketed in Great Britain (GB) only. PDNs currently remain valid in Northern Ireland.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published an update on the digital mental health technologies (DMHTs) regulation project that launched in 2023. The first work package of the project, which involved mapping out the landscape of available DMHTs and their key characteristics, has been concluded. The key findings of this work have included the development of a conceptual framework for categorising DMHTs, considerations for regulation and evaluation informed by literature and stakeholder insights and clearer proposals for how DMHTs qualify as Software as a Medical Device. A summary report has also been published which has found, in the main, that while DMHTs were perceived as having the potential to make a valuable contribution to the management of health, they should be used as part of a wider treatment package, alongside regular therapy sessions and/or regularly reviewed, prescribed medication.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published an update to its March 2025 government response on statutory fees. The update focuses on Proposal 2 of the original consultation—the introduction of a new annual medical devices registration fee to support post-market surveillance (PMS) activities.

The Medicines and Healthcare products Regulatory Agency (MHRA) has collated the information on the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, SI 2025/87, which come into effect on 23 July 2025, in a new ‘Decentralised manufacture hub’. The hub will contain regulatory guidance to clarify expectations on decentralised manufacture once the legislation is in force. The guidance is expected to be published in early summer 2025 and will cover clinical trial authorisation and good clinical practice, designation, labelling, marketing authorisation applications and pharmacovigilance, among other issues.

The Medicines and Healthcare products Regulatory Agency (MHRA) has conducted raids on two premises in Lincolnshire and Nottinghamshire as part of an ongoing investigation into an organised criminal network involved in manufacturing unlicensed weight loss medicines. The Criminal Enforcement Unit (CEU), supported by Lincolnshire Police, Immigration Enforcement and Lincolnshire Trading Standards, seized almost 2,000 doses of unauthorised weight loss medicines awaiting dispatch to customers, alongside manufacturing equipment, suspected pharmaceutical ingredients, packaging and commercial vehicles. The premises searched comprised a farm near Sleaford and a residential address in Grantham, believed to have been used for manufacturing and distributing unlicensed weight loss medicines including retatrutide and tirzepatide, as well as peptide products. The operation follows a previous raid in October 2025 in which CEU officers dismantled what the MHRA described as the UK's first illicit weight loss medicine manufacturing facility in Northampton.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the government has tabled amendments to the Health Bill to support reforms to the UK framework for medicines and medical devices regulation. The amendments cover information sharing powers for medicines and medical devices, measures to make medicines and medical devices legislation easier to update, and powers to support the future development of a medical device licensing regime. The MHRA states that the proposals do not introduce immediate changes to the regulation of medicines or medical devices and that any future measures would be subject to further development and consultation before implementation.

The Medicines and Healthcare products Regulatory Agency (MHRA) has released the application form for manufacturers who want to apply for approval to supply a non-UK Conformity Assessed (UKCA) marked medical device on humanitarian grounds. The MHRA may authorise manufacturers to supply a non-UKCA marked medical device in the interest of the protection of health under regulation 12(5) of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a decision tree to guide researchers and developers through the regulatory landscape for nanomedicine products, with a focus on lipid nanoparticles. This tool, released on 5 February 2025, aims to clarify the application of various guidelines from the International Council for Harmonisation (ICH) and European regulatory agencies to nanomedicine development. The MHRA emphasises that while the decision tree covers classification, new active substances, and 'nanosimilar' pathways, it is not exhaustive and does not replace the need for specific regulatory or scientific advice meetings.

The MHRA has released a collection of guidance documents to support medical device manufacturers implement the new Post-market surveillance (PMS) regulation SI for medical devices in Great Britain (GB) which will come into force on the 16th June 2025.