21st July 2025 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published its June 2025 decisions following investigations into complaints about advertising for licensed medicines. See here for further information on the decisions.
• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Jazz Pharmaceuticals UK Ltd has brought discredit upon the pharmaceutical industry in two cases: Case AUTH/3917/6/24 and Case AUTH/3918/6/24
• The European Commission has now published the final version of the General-Purpose AI Code of Practice. See European Commission press release for further information.
• The European Commission has confirmed that it is not intending to delay the implementation or enforcement of the AI Act despite various groups lobbying for a more relaxed approach to implementation. At a press briefing on 4th July, a Commission spokesperson ended speculation. See press briefing for further information.
• The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on ICH E21 guideline on the inclusion of pregnant and breastfeeding individuals in clinical trials. The consultation is open until 5th September 2025. See MHRA press release for further information.
• The European Commission has launched a consultation on the future of the EU procedures for the application of EU competition rules. The consultation is open until 2 October 2025. See European Commission press release for further information.
• The European Commission has fined Alchem for breaching EU competition law rules, specifically for participating in a cartel concerning an important pharmaceutical ingredient. See European Commission press releases here and here for further information.
• The Swiss Competition Authority has published the non-confidential version of its latest decision in the investigations into Novartis over its alleged acquisition and use of “blocking patents” to exclude competitors. The decision explains the reasons for concluding that Novartis’ actions did not constitute an abuse of a dominant position. See Decision for further information.
• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its position paper on the Critical Medicines Act, stating that “EFPIA stands ready to work with the EU institutions and all stakeholders to ensure that the CMA delivers on its objectives, while maintaining Europe’s leadership in pharmaceutical innovation and manufacturing.” See EFPIA position paper for further information.
• The European Commission has announced two new initiatives on EU stockpiling and medical countermeasures strategies aimed at improving access and ensuring continuity of medical supplies, particularly in times of crisis. See European Commission press release for further information.
• The European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) have issued a joint Opinion on the European Commission’s proposal for a Regulation amending certain regulations including GDPR. The proposal aims to simplify EU rules and reduce administrative burden. See Joint Opinion for further information.
• The MHRA has updated its information hub on the new regulations for decentralised manufacturing to include a link to an update webinar recording, which took place on 17 June 2025. See information hub here for further information and link to webinar.
• EFPIA has published a guest blog on the access implications of the proposed new EU regulatory framework for pharmaceuticals. See here for further information.
• The Intellectual Property Office (IPO) has updated the Manual of Patent Practice section on Supplementary Protection Certificates for Medicinal and Plant Protection Products. The changes are significant including a new Annex III. See IPO announcement for further information.
• The European Commission has opened a new consultation on the EU Good Manufacturing Practice (GMP) guidelines, specifically to look at the guidelines in light of advancements in digital technologies and AI systems in pharmaceutical manufacturing. The consultation is open until 7 October 2025. For further information on the consultation, see here
• The government has confirmed its intention amend the Medical Devices Regulations 2002 for Great Britain to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices, which will create consistency with the European regulations and reduce administrative burden. See MHRA press release and government response to consultation on common specification requirements for in vitro diagnostic devices for further information.
• The MHRA has updated its guidance for digital mental health technology: qualification and classification. See updated guidance here
• The MHRA has published guidance for manufacturers on the standardised format for the periodic safety update report (PSUR) in medical devices. See here for further information.
• The MHRA has updated its information hub on the AI Airlock (regulatory sandbox for AI as a medical device) to include a new webinar recording on the pilot and phase 2. See here for further information and link to webinar.
• The Association of the British Pharmaceutical Industry (ABPI) has highlighted that inequalities in access is a patient safety issue. The ABPI commentary follows publication of the independent review by Penny Dash of patient safety across the health and care landscape in England. See review for further information.
• The European Commission has launched a new life sciences strategy aimed at making Europe a global leader in life sciences by 2030. See European Commission press release for further information. EFPIA has commented on the new strategy. See here for further information.
• The UK Government has published its 10-year Health Plan for England, setting out its vision for reform of the NHS in England based around a move from hospital to community care. The plan includes some potentially important measures on medicines, including an expanded role for NICE to re-evaluate clinical pathways on a rolling basis, a single national formulary and new commercial arrangements for innovative treatments. See detailed policy paper here. See ABPI response to the plan here. NICE has also commented on the plan see here and the Health Research Authority (HRA) comments are available here

Artificial Intelligence (AI)

EU

Clinical Trials

UK

Competition Law

EU

Switzerland

Critical Medicines Act and Medicines Shortages

EU

Data Privacy

EU

Decentralised Manufacturing

UK

EU Pharma Law Reform

EU

Intellectual Property

UK

Manufacturing

EU

Medical Devices

UK

Patient Safety

UK

Policy, Strategy and Trade

EU

UK

• The HRA has published its strategy for 2025-2028. See here 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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