8th August 2025 Update

Artificial Intelligence (AI)

EU

• The EU AI Act obligations for providers of general-purpose AI (GPAI) models have entered into force. For further commentary see European Commission press release
• The European Commission has published its Opinion on the general-purpose AI Code of Practice and determined that it is an adequate voluntary tool for providers of GPAI models to demonstrate compliance with the AI Act. The AI Board has also published its adequacy assessment of the general-purpose AI Code of Practice. Both can be accessed here

Biotech Act

EU

• The European Commission has opened a public consultation on the Biotech Act. The consultation is open until 10 November 2025. For further information including how to provide feedback, see here.

Clinical Trials

UK

• The Health Research Authority (HRA) has published the findings of its survey on simplifying arrangements for the consent process in certain clinical trials. The published findings are available here
• The HRA has updated a number of it commercial model agreements for use with participating NHS and HSC organisations to align with the model Commercial Chief Investigator Agreements published in June 2025. See here for further information, including which model agreements have been updated.

Data Privacy

UK

• The Information Commissioner’s Office (ICO) has published new guidance on disclosing documents to the public. For further information see here

Homecare

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published a new report on the potential of homecare services and the role of the pharmaceutical industry in delivering critical homecare. See ABPI press release for further informaiton, including link to the Report.

Market Access

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) have issued a press release confirming that under a joint information sharing agreement, pharmaceutical companies will be invited to register early with the MHRA and NICE to allow parallel decision making over licencing and value. It is proposed that the plan could lead to faster access to medicines at the same time they are licensed in the UK. See MHRA press release or NICE press release for further information.

Medical Devices

UK

• The MHRA has set out its initial plans in a Statement of Policy Intent on an early access service aimed at helping patients benefit sooner from innovative medical devices that address unmet clinical need. See MHRA press release and Statement of Policy Intent for further information.
• The MHRA has published guidance for manufacturers of digital mental health technologies that qualify as software as a medical device on understanding new post market surveillance rules and how they apply. See here for further information including the Guidance.

Policy, Strategy and Trade

EU

• The European Commission has published a statement by the President, Ursula von der Leyen, on the deal on tariffs and trade reached with the United States. See Statement here. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has also published its response to the EU-US trade deal. See here for further information.

UK

• The World Health Organisation (WHO) has designated the MHRA as a WHO-Listed Authority. The designation recognises the UK authority as an authority with the highest standards in the regulation of medicinal products. See MHRA press release for further information.

Product Liability

UK

• The Law Commission has announced that it is to review the law relating to product liability and will begin the work in 2025. See the announcement here and further information here.

Regulatory

EU

• The European Medicines Agency (EMA) has opened a public consultation on a concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease. The consultation is open until 28 February 2026. See here for concept paper and how to provide feedback.