The MHRA has updated its clinical trial guidance to accompany the UK’s post-Brexit reform of the clinical trials framework. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, which significantly amends the Medicines for Human Use (Clinical Trials) Regulations 2004 (MHU(CT)R 2004), SI 2004/1031, will take effect from 28 April 2026. The MHRA explains that parts of the guidance is in draft and should only be used to support sponsors in preparing for the implementation of the new regulations. Updates include changes to the approval pathway, notifiable trials, new documents on Route A and B for modifying a clinical trial approval and a new dedicated page for clinical trials that include an in vitro diagnostic device and clarification on transitional arrangements.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on defective medicinal products and on substances used in their manufacture or packaging that may be defective. The revised guidance reflects the introduction of an online reporting form for industry stakeholders to notify the Defective Medicines Report Centre (DMRC) of suspected defective products and includes minor editorial amendments.

The Medicines and Healthcare products Regulatory Agency (MHRA) has revised its 'Guidance note on good pharmacovigilance practices' to incorporate the latest version of exceptions and modifications to EU guidance applicable to UK marketing authorisation holders (UK MAHs) and the licensing authority. This update follows recent changes to UK legislation implementing new arrangements for medicines in line with the Windsor Framework agreement, and aligns with EU updates to  good pharmacovigilance practices module XVI. The guidance clarifies expectations for applying EU good pharmacovigilance practices in the UK context, detailing aspects that no longer apply or require modification for MHRA and UK MAHs.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published amendments to the guidance on its website setting out changes to the way updates to a marketing authorisation holder's (MAH) pharmacovigilance (PV) system should be notified. The changes reduce administration burden for both MAHs and the MHRA and no longer require the submission of a Type IAIN variation. Previously Type IAIN variations to marketing authorisations had to be submitted to the MHRA within 14 days of the variation. These changes came into effect on 11 May 2023 and guidance was further updated on 17 November 2023. The MHRA website is now updated but some related documents–including the guidance on qualified person responsible for pharmacovigilance including Pharmacovigilance System Master Files (PSMF)–do not as yet reflect the changes. It is important to note that there have been no changes made to the way MAHs should request PSMF numbers or submit applications for marketing authorisations.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on transitional arrangements for the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, which comes into force on 28 April 2026. The update clarifies timelines for submitting notification of intent to follow old pharmacovigilance rules, confirms that substantial labelling updates to comply with the amended regulations must be approved by the MHRA and adds guidance on post-QP certification labelling on or after 28 April 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the labelling and packaging of medicinal products for human use in light of the agreement on the Windsor Framework. The updates include a new glossary, amended terminologies to ensure alignment with the Windsor Framework, a new section on supply of existing stock in existing packs and a new section on the packaging requirements for traditional herbal and homeopathic medicinal products.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated several variations forms for a manufacturer’s licences, including forms 9V and 10, which are used for variations to an existing site named on a manufacturer's licence and for adding a new site to a manufacturer's licence. These updates, published on 14 July 2025, apply to Manufacturer’s Licences (MIA), Wholesale Dealer’s Licences for Specials (MS), and Manufacturer’s Licences for Investigational Medicinal Products (MIA(IMP)). Additionally, the MHRA has released updated application forms for new MIAs covering human use, investigational medicinal products, and the manufacture of unlicensed 'specials' medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its pharmacovigilance procedures guidance with new information on periodic safety update reports (PSURs) in relation to the European Union Reference Date (EURD) list in section 5.2 of the guidance. The EURD is the European Medicines Agency’s repository of individual and combined active substances contained in authorised medicinal products. Notwithstanding Brexit, MHRA continues to require PSURs for UK products to be submitted in accordance with the EURD list. The updates clarify that marketing authorisation holders (MAHs) should continue submitting PSURs even where the relevant active substance is removed from the EURD list, unless informed otherwise by the MHRA.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a revised roadmap outlining the implementation timeline for the future medical devices regulatory framework. This update follows the agency's consultation on routes to market and in vitro diagnostic devices, launched in November 2024. The MHRA has also laid a draft Post-Market Surveillance statutory instrument in Parliament and released a statement of policy intent for international recognition of medical device approvals. These developments mark significant steps in the UK's ongoing reform of medical device regulations post-Brexit.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the application date for groundbreaking new UK legislation has arrived from 23 July 2025. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, SI 87/2025 will provide the world's first regulatory framework that allows breakthrough personalised medicines such as cancer and immunotherapy (ie CAR-T) treatments to be prepared in small or individual batches. It aims to transform the manufacture of innovative medicines at the point of patient care.

The Medicines and Healthcare products Regulatory Agency (MHRA), together with the Advertising Standards Authority (ASA) and the General Pharmaceutical Council (GPhC), has issued an updated joint enforcement notice to clarify the rules on advertising prescription-only medicines (POMs) for weight management. The notice, directed primarily at pharmacies, provides guidance on prohibited advertising practices. Advertisers must avoid: (1) using terms referring to POMs such as ‘weight-loss injection’, ‘obesity treatment jab’ or ‘GLP-1’; (2) including imagery likely to be interpreted as denoting prescription medicines; and (3) advertising general weight-loss products and services in a way that directs consumers to other advertisements, such as website landing pages, that promote POMs. The MHRA confirmed that it has already taken action against more than 25 businesses in 2025 for promoting prescription-only weight-loss medicines to the public.

Life sciences analysis: The Medicines and Healthcare products Regulatory Agency (MHRA) has jointly published new transparency guiding principles for machine learning medical devices (MLMDs). The latest guidance builds on previous principles for good machine learning practice for medical device development, which the MHRA published with international regulators the FDA and Health Canada in 2021. Rory Trust and Annalise Slocock of Burges Salmon LLP consider the new transparency guiding principles.