6th February 2026 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has published revised social media guidance as a new dedicated section of its website, with links to completed cases and Q&As. See here for further information.
• The PMCPA has ruled that Sanofi has breached the ABPI Code of Practice for the Pharmaceutical Industry (Code), following its publication of an article in a Sunday newspaper that was based on an interview with a senior global leader. The PMCPA has ruled that the article promoted Sanofi’s medicine to the public as well as making misleading claims and disparaging a competitor medicine. The PMCPA ruled that Sanofi breached clauses 2, 5.1, 6.1, 6.2, 6.6, 26.1 and 26.2 of the 2024 Code. See Sanofi Limited – Case/0518/03/25 for further information.

Artificial Intelligence (AI)

EU

• The European Commission has established a signatory taskforce for the General-Purpose AI Code of Practice to facilitate coherent application of the Code. See here for further information.

UK

• The UK Government has published its progress report on delivering the AI Opportunities Action Plan. See here for further information.
• The Department for Science, Innovation and Technology (DSIT) has published a survey of AI adoption and use in the UK’s engineering biology community. The findings are intended to inform future policy development. See here for further information.
• Following the commission of a research project to explore the artificial intelligence skills needed for life and work in the UK, DSIT has just published eleven reports which look at AI skills in the UK. See here for further information.
• The UK Government has just published a summary of a proposal for a regulation amending EU regulations 2024/1689 and 2018/1139 on simplification of rules on artificial intelligence. See here for further information.

Clinical Trials

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on Clinical Trials for Medicines: labelling. See here for further information.
• The Health Research Authority (HRA) has published new guidance for the set-up of NHS studies involving ionising radiation. See here for further information.
• The HRA has published a blog article explaining proposed changes to definitions and terminology used in relation to clinical trials of investigational medicinal products, which will be introduced on 28 April 2026 when the new regulations for clinical trials come into force. See here for further information and further guidance here.
• A Memorandum of Understanding (MOU) between the PMCPA and the HRA has been published and came into force on 1 February 2026. The MOU sets out the regulatory responsibility between the PMCPA and the HRA in relation to the handling of complaints about UK participant-facing clinical trial materials. The MHRA was also consulted. See here for further information including a link to the MOU.

Data Privacy

UK

• The latest phase of the Data (Use and Access) Act implementation came into effect on 5^th February 2026, with most of the remaining provisions of the Act now in force. See Information Commissioner’s Office (ICO) statement here and DSIT Guidance here.
• The ICO has published updated guidance on how it handles data protection complaints. See here for further information.

Enforcement

UK

• The MHRA has announced that it seized almost 20 million doses of illegally traded medicines during 2025. See MHRA press release for further information.

Health Data

EU

• The European Commission is seeking feedback on draft guidelines for calculating reasonable compensation under the Data Act. The consultation is open until 20^th February 2026. See here for further information including how to contribute to the consultation.

Market Access

UK

• National Institute for Health and Care Excellence (NICE) has published a new national healthtech access programme. The approach will expand NICE’s technology appraisals programme to include health technologies. NICE has now announced the first two topics to go through the new programme. See NICE press release for further information.

Medical Devices

UK

• The MHRA has published new guidance for people using mental health apps and technologies. See here for further information.
• The International Medical Device Regulators Forum has published its strategic plan 2026-2030. See here for further information.

Product Liability

UK

• The Law Commission has launched its first review of product liability in almost 50 years. See Law Commission Review Terms of Reference here.

Regulatory

EU

• The European Medicines Agency (EMA) has published its Human Medicines Highlights for February, including new information on approved medicines and new medicines recommended for approval. See here for further information.

• The EMA has published (for consultation) a concept paper on the revision of the Guideline on Clinical Evaluation of Diagnostic agents and its appendix 1 on imaging agents. The consultation is open until 30 April 2026. See here for further information, including how to contribute to the consultation.

Research and Development

EU

• The EMA has published (for consultation) a concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development. The consultation is open until 30 April 2026. See here for further information, including how to contribute to the consultation.

Safety

UK

• The MHRA has published its Safety Roundup for January 2026. See here for further information.
• The MHRA has updated guidance for GLP-1 prescribers and patients regarding the risk of severe acute pancreatitis in some patients taking GLP-1s. See MHRA press release for further information and further guidance here.

Strategy Policy and Trade

UK

• The UK Government has published its National Cancer Plan for England. See policy paper The Association of the British Pharmaceutical Industry (ABPI) has published a response to the National Cancer Plan and is broadly in favour of the Plan’s aims and ambition to make meaningful improvements in patient care. See ABPI response here.
• The ABPI has published a blog article exploring what really drives company decisions in launching a new medicine and how policy decisions, particularly on investment can influence company decisions. See here for further information.
• The UK and Japan have announced a major package of science and technology collaborations including a multi-million pound investment into UK life sciences’ gene therapy industry and a partnership to deliver a national rare disease genomics pilot for Japan. See UK Government press release for further information.
• The Secretary of State for Science, Innovation and Technology delivered a speech at the Bio Industry Association on 29 January 2026. See here for further information.