19th May 2025 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published its decisions on advertising investigations for April 2025. See here for further information.

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Moderna has breached Clauses 2 and 5.1 of the 2021 Code for failing to include all relevant information in its submission for a previous case. See Case/0316/10/24 – Complainant v Moderna

Artificial Intelligence (AI)

EU

• The European Commission has published analysis of stakeholder feedback on AI definitions and prohibited practices public consultations. See European Commission press release for further information.

• The European Commission has published an FAQ on AI literacy. See here for further information.

• The European Medicines Agency (EMA) and the Heads of Medicines Agencies have published a joint workplan “Data and AI in medicines regulation to 2028”. The report sets out how the European regulatory network plan to leverage data and new tools to support regulatory decision making. See EMA press release for further information.

Ireland

• Ireland’s AI Advisory Council has published a report highlighting strategic recommendations for harnessing the future of AI in Ireland. See here for further information.

UK

• An AI system to detect potential skin cancer has been conditionally recommended for use in the NHS by NICE. See NICE press release for further information.

Biotech Act (EU)

EU

• The European Commission has published a call for evidence for its planned Biotech Act proposal. The feedback period is open until 11 June 2025. See here for further information, including how to respond to the consultation.

Clinical Trials

UK

• The Health Research Authority (HRA) has published changes to model agreements that should be used in research across the UK. The changes affect the Model Commercial Chief Investigator Agreement and the Model Confidential Disclosure Agreements. See HRA press release for further information.

Critical Medicines

EU

• The European Commission has published presentation materials from an information session it held on the Commission’s proposal for a Critical Medicines Act. See here for further information.

Competition Law

UK

• The Court of Appeal has unanimously upheld the Competition and Markets Authority’s (CMA) finding that Advanz broke the law by overcharging the NHS for essential thyroid drug liothyronine. See CMA press release for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) has adopted an opinion on the European Commission’s proposal to extend the validity of the UK adequacy decisions under the GDPR and the Law Enforcement Directive, which are due to expire on 27 June 2025. See EDPB opinion here

UK

• The Information Commissioner’s Office (ICO) has published a consultation on draft updated guidance on encryption. The consultation is open for public consultation until 24 June 2025. See here for further information.

• The UK Data (Use and Access) Bill has passed its third reading in the House of Commons and returns to the House of Lords for consideration of the House of Commons amendments. See here for further information.

Intellectual Property

UK

• The UK government has confirmed it will maintain the current exhaustion of rights regime, providing certainty for business. See Intellectual Property Office (IPO) press release for further information.

Manufacturing

EU

• The EMA has published a concept paper for consultation on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products. The consultation is open until 8 July 2025. See here for further information.

Market Access

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published two reports which illustrate the ongoing difficulties of ensuring equal access to medicines for all. See EFPIA press release for further information.

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published its response to the consultation on proposals to update the statutory scheme to control the costs of branded health service medicines. See ABPI response and press release for further information.

Medical Devices

UK

• The MHRA has updated its guidance for manufacturers on post-market surveillance to provide the latest information regarding the MORE portal and reporting. See further information on the MORE portal here and here

Policy, Strategy and Trade

EU

• The European Commission has concluded its consultation on the Strategy for European Life Sciences which has attracted a wide range of responses. See European Commission press release for further information.

UK

• The ABPI has commented on the UK-US trade agreement. See ABPI press release for further information.

• The ABPI has expressed disappointment that the new free trade agreement with India does not address longstanding concerns around intellectual property protections. See ABPI press release for further information.

Rare Diseases

Global

• The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has issued a joint statement with EFPIA supporting the World Health Assembly Resolution and Global Action Plan on Rare Diseases. See IFPMA press release for further information.

Regulatory

EU

• EMA has published its Human Medicines Highlights for May 2025, including information on new medicines and CHMP Opinions. See here for further information.

• EMA has published a concept paper for consultation on the revision of the guideline on the evaluation of anticancer medicinal products and appendices – Revision 7. The consultation is open until 31 July 2025. See here for further information.

• EMA has published a concept paper for consultation on the draft ICH Q1 guideline on stability testing of drug substances and drug products – Step 2b. The consultation is open until 30 July 2025. See here for further information.

UK

• The MHRA has published the consultation outcome from its consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2. See MHRA press release for further information.

• The MHRA has opened a consultation on the International Council for Harmonisation (ICH) M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms. The consultation is open until 31 July 2025. See MHRA press release for further information.

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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