25th July 2025 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that LEO Pharma has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry for the inclusion of misleading and inaccurate information in an app for patients and failure to remove the information immediately. For further information see CASE/0349/11/24 and CASE/0350/11/24.
• The PMCPA has ruled that Theramex HQ UK Ltd has breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon and reduced confidence in the pharmaceutical industry for its failure to provide accurate and complete prescribing information and promptly update prescribing information, not disclosing the details of two non-interventional studies in the appropriate manner, and the quality of relevant process documentation. For further information see CASE/0303/09/24.

Artificial Intelligence (AI)

EU

• The European Parliament has published a study on AI and civil liability, which analyses the European Union’s approach to regulating civil liability for artificial intelligence systems. The study recommends revising the AI Liability Directive to introduce a strict liability regime for high-risk AI systems. See Artificial Intelligence and Civil Liability Study for further information.
• The European Commission has published guidelines for providers of general-purpose AI models. The guidelines clarify the AI Act obligations for providers and complement the General-Purpose AI Code of Practice. See European Commission press release for further information.

UK

• The Minister of State, Department of Science, Innovation and Technology (DSIT) noted in Parliament that the UK government was preparing a consultation on AI legislation. The issue was raised in the Lords on Monday 21st July. See debate in Hansard for further information.

Clinical Trials

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted how the clinical trial community have issued a warning to EU policy makers that without urgent implementation of the Life Science Strategy, Europe’s clinical trial eco-system faces significant challenges. A broad group of clinical trials stakeholders has published a report setting out actions now needed. For further information see EFPIA press release and report

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting with UK stakeholders to gather feedback and comments on a new international guideline ICH E20, on the design, conduct, analysis, and interpretation of adaptive clinical trials. The consultation is open until 30 November 2025. For further information on the consultation see here

Data Privacy

EU

• The European Commission has published a draft renewal of the adequacy decision for UK data transfers. See here for further information.
• EFPIA has submitted its GDPR Code of Conduct on clinical trials and pharmacovigilance to the Belgium data protection authority for formal assessment. The step is aimed at trying to support a consistent interpretation of key GDPR provisions as they apply to pharmacovigilance and clinical research. See EFPIA press release for further information.

UK

• The Data Use and Access Act 2025 has now been published. For further information on the implementation of the Act see here. For the detailed regulations see here

Decentralised Manufacturing

UK

• The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 came into force on 23 July 2025. The regulations, introduced by the MHRA, allow breakthrough personalised medicines to be prepared in small or individual batches. See MHRA press release for further information and the MHRA decentralised manufacture hub for supporting guidance and updates.

Freedom of Information

UK

• The Supreme Court issued a judgement on 23 July 2025, clarifying that when applying exemptions under the Freedom of Information Act which are subject to the public interest test, the public interest factors for and against disclosure of the information can be considered cumulatively. See here for further information on the judgement.

Medical Devices

UK

• The MHRA has now published the Government’s response to its public consultation on the future routes to market for medical devices. The proposals are aimed at improving patient access to new technologies and boosting med tech industrial growth. See MHRA press release for further information. The consultation response is available here

Pharmacovigilance

EU

• On 23 July 2025, the European Commission Implementing Regulation of 22 July 2025 which provides for tailored updates to the rules on the performance of pharmacovigilance activities for medicinal products was published in the Official Journal. Most of the provisions (apart from a few which apply from 12 August 2025) apply from 12 February 2026. See Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council

Policy, Strategy and Trade

EU

• EFPIA has published a preliminary response to the European Commission multiannual financial framework package, stating that “we do not believe that the health and health research innovation have been sufficiently prioritised despite their strategic importance for Europe’s competitiveness and security.” See EFPIA press release for further information.

UK

• The UK government published its Life Sciences Sector Plan on 16th July 2025. The Plan includes several positive initiatives which set the context for enabling World class research and development, driving innovation and NHS reform as well as making the UK a place to invest. See Plan and press release for further information. The Association of the British Pharmaceutical Industry (ABPI) has stated that it considers the plan “falls short” and does not believe the government’s life sciences strategy will be realised until there is a real commitment to invest in new medicines. See ABPI press release here. See NICE response here and the Health Research Authority (HRA) response here.
• Steve Bates OBE has been appointed as the new executive Chair for the Office of Life Sciences. See here for further information.
• The ABPI has appointed Laura McMullin of Daiichi Sankyo as the new ABPI Vice-President. See ABPI press release for further information.

Regulatory

EU

• The European Medicines Agency (EMA) has opened a consultation on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making. The consultation is open until 31 October 2025. See here for further information including how to contribute to the consultation.
• EMA has published its Human Medicines Highlights for July 2025, including new information on approved medicines and new medicines recommended for approval. See here for further information.

UK

• The MHRA in collaboration with DSIT has opened a call for evidence on the operation and impact of the UK’s medicines and medical device regulatory framework as part of a statutory review under the Medicines and Medical Devices Act 2021. The call for evidence is open until 19 September 2025. See here for further information.