16th October 2025 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published decisions made by it following investigations about licensed medicines for September. See here for further information.
• The MHRA in partnership with the Advertising Standards Agency (ASA) has jointly released an updated Enforcement Notice to reaffirm the advertising rules for prescription-only medicines used for weight management. See MHRA press release for further information.

Artificial Intelligence (AI)

EU

• The European Commission has published draft guidance and a reporting template on serious AI incidents and is seeking stakeholder feedback in a public consultation. The consultation is open until 7 November 2025. See here for further information, including how to provide feedback.

UK

• The UK government has announced that a new UK National Commission on the Regulation of AI in Healthcare is to be set up to help accelerate the safe use of AI in healthcare and across the National Health Service (NHS). See MHRA press release for further information.

Clinical Trials

EU

• The European Commission, the Heads of Medicines Agencies and the European Medicines Agency (EMA) have jointly developed two new targets for clinical trials. The targets will monitor progress against the EU stated aims of making Europe an attractive environment for clinical research. See EMA press release for further information.

UK

• The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 come into force on 28 April 2026. The MHRA has significantly updated its Guidance on clinical trials for medicines that should be followed post 28 April 2026. See Medicines:clinical trials hub for further information. The MHRA has additionally published new Guidance on Clinical trials that include an in vitro diagnostic device
• The Health Research Authority (HRA) has published its final guidance to support the introduction of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. See HRA press release and final guidance for further information.
• The HRA has updated the information governance section of the study wide governance review criteria for the UK. See here for further information.

Competition Law

EU

• The European Commission has carried out unannounced inspections at the premises of a company active in the vaccines sector which are a preliminary investigative step when anticompetitive practices are suspected. See European Commission press release for further information.

France

• On 23 September 2025, the French Competition Authority, Autorité de la Concurrence carried out an unannounced inspection at the premises of a company suspected of having carried out anti-competitive practice in the oncology sector. See press release for further information.
• On 24 September 2025, the Court of Appeal, Paris ordered Sanofi to pay €150.7 million in damages to the French national health insurance fund, following an earlier decision of the French Competition Authority which found that Sanofi abused its dominant position by disparaging generic versions of its antiplatelet medicine, clopidogrel. See press release (in French) for further information.

UK

• Following consultation, the Competition and Markets Authority (CMA) has recommended that the Secretary of State for Business and Trade replace the Assimilated Technology Transfer Block Exemption with a UK block exemption order. See final recommendation and consultation outcome for further information.
• A Memorandum of Cooperation has been reached between the CMA and the Fair Trade Commission of Japan concerning the application of their competition laws. See CMA press release for further information.
• The Subsidy Advice Unit has published a report providing advice to the Office of Life Sciences concerning its proposed Life Sciences Large Investment Portfolio Scheme. See CMA press release for further information.
• Several UK advocacy organisations, including The Balanced Economy Project, Just Treatment and Global Justice Now have urged the CMA to investigate major pharmaceutical companies for allegedly engaging in anti-competitive behaviour, by coordinating withdrawal from UK investments in order to increase drug prices. See letter to the CMA here

Critical Medicines

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an article on the industry’s vision for the Critical Medicines Act, following an event in the European Parliament. See EFPIA press release for further information.

Data Privacy

UK

• The Information Commissioner’s Office (ICO) has published cybersecurity guidance for small businesses. See here for further information.

Market Access

UK

• The National Institute for Health and Care Excellence (NICE) has announced that it will apply the same standards to evaluate medical devices, diagnostics and digital tools that it uses to assess new medicines. Technologies meeting NICE standards will receive recommendations for NHS wide implementation, supported by guidance on value and effectiveness. See NICE press release for further information.
• The Association of the British Pharmaceutical Industry (ABPI) and the UK government have agreed to a four-week extension of the deadline by which companies need to give notice if they intend to leave the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). The deadline has been extended to 31 October 2025. See ABPI press release for further information.

Packaging

EU

• The Court of Justice of the European Union (CJEU) is to clarify the rules on packaging requirements in parallel trade of medicines following a preliminary request from the German Federal Administration Court (Bundesverwaltungsgericht). See Case C-354/25 -Request for Preliminary Ruling

Pharmaceutical Law Reform

EU

• EFPIA has published a blog article on Europe’s pharmaceutical law reform. See here for further information.

Policy, Strategy and Trade

EU

• A new report commissioned by EFPIA has highlighted that the lack of understanding about the cost-benefit of innovative cancer treatments, lack of funding and move of oncology research away from Europe could impact the potential survival rates and quality of life for cancer patients. See EFPIA press release for more information including link to the report.
• The European Commission has launched a new strategy to strengthen Europe’s research and technology infrastructures. See here for further information.

UK

• There continues to be considerable media coverage regarding the challenging operating environment in the UK for pharmaceutical companies and decline in NHS spending on medicines, making the UK an unattractive market. The ABPI has posted a blog article highlighting concerns of industry and the tension between the need to control costs whilst ensuring innovation is properly valued. See ABPI blog for further information.
• The ABPI has launched its manifesto for the Scottish Government, calling for action to ensure Scotland can become a leader in research and innovation. See ABPI press release for further information.
• The UK government is piloting a new £50 million Life Sciences Transformational R&D Investment Fund to support large-scale, capital-intensive projects in the life sciences sector worth over £100 million. For further information, including how to apply to the Fund, see here

Regulatory

EU

• The EMA has published a draft reflection paper on patient experience data for public consultation. The consultation is open until 31 January 2026. See here for further information including how to contribute.
• The European Commission has published new Variations Guidelines to better streamline the lifecycle management of medicines. See EMA press release and Variations Guidelines for further information.
• The EMA has published its Human Medicines Highlights for September 2025, with information on new medicines recommended for approval and new information on approved medicines. See here for further information.

Safety

UK

• The MHRA has published its safety round-up for September 2025. See here for further information.

Telemedicine

EU

• The CJEU has determined which rules govern the concept of telemedicine in the context of a dispute, clarifying that the law of the service provider’s country of origin will apply. See Case C-115/24

Transparency

UK

• The Prescription Medicinces Code of Practice Authority (PMCPA) has published new guidance about changes to requirements for the methodological note document applicable to 2025 HCP/HCO disclosures. For further information including the guidance see here.