14th April 2025 Update

Advertising

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a blog article on the legitimate need for promotion of medicines in the pharmaceutical industry. See here for further information.

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has updated Appendix 4 (Best Practice Guidance) of the Blue Guide. See here for further details of the update.

• The MHRA has published its March 2025 decisions following investigations into complaints about advertising of licensed medicines. See MHRA March decisions here

Artificial Intelligence (AI)

EU

• The European Commission has published updated living guidelines on the responsible use of AI in research. See here for further information.

• The European commission has published the AI Continent Action Plan, outlining plans for Europe to become a global leader in AI. See here for further information.

• The European Commission has launched a consultation on the future cloud and AI policies in the EU. The consultation is open until 4 June 2025. See here for further information and how to contribute.

• The European Commission has published its Digital Europe work program for 2025-27, emphasising AI integration and cybersecurity. See European Commission press release for further information.

Biosimilars

EU

• The European Medicines Agency (EMA) has published a draft reflection paper on potential improvements to the development and evaluation of biosimilar medicines. Stakeholders are invited to comment on the reflection paper until 30 September 2025. See here for further information and how to comment on the reflection paper.

Clinical Trials

EU

• The Clinical Trials Information System has been designated a World Health Organisation primary registry. See European Medicines Agency press release for further information.

UK

• The updated Clinical Trial Regulations have now become law. The new Regulations will become effective from 10^th April 2026. See MHRA press release for further information.

• The MHRA has published two webinar recordings providing information about plans for implementation of the new Clinical Trials Regulations. See here for further information.

Competition Law

Switzerland

• The Swiss Competition Authority has fined several pharmaceutical companies for their involvement in a cartel in relation to N-Butylbromide Scopolamine/Hyoscine (SNBB), the active ingredient of the anti-cramp medicine Buscopan® and its generic versions. See press release of the Swiss Competition Authority for further information.

Cybersecurity

EU

• The European Commission has launched a consultation on the Action Plan for the cyber security of hospitals and healthcare providers. The consultation is open until 30 June 2025. For further information including how to contribute see here

UK

• The UK government has announced the scope of the Cyber Security and Resilience Bill. See press release for further information including details of the Government’s plan and policy statement.

• The Department of Science, Innovation and Technology (DSIT) has published a Cyber Governance Code of Practice, providing information for businesses on how to manage digital risks and protect their businesses and organisations from cyber attacks. See here for further information.

Data Privacy

EU

• The European Data Protection Board has published a report on AI privacy risks and mitigations for large language models. See here for further information and access to the report.

UK

• The Information Commissioner’s Office (ICO) has published updated guidance on anonymisation. See ICO guidance for further information.

Health Data

UK

• The Prime Minister has announced the creation of a new UK wide health data research service. The Government and the Wellcome Trust will invest up to £600 million to create the new service. See UK government press release for further information. See also ABPI press release

Innovative Medicines

UK

• The MHRA has published guidance on submission and assessment timetables for innovative medicine applications. See guidance here

• The MHRA has updated its guidance on the Innovative Licensing and Access Pathway (ILAP). See updated guidance here

Intellectual Property

UK

• The Intellectual Property Office has updated the Manual of Patent Practice. See here for further information.

Medical Devices

EU

• EMA has published an interim report on the scientific advice pilot for medical devices. See here for updated press release and access to the report.

UK

• The MHRA has published guidance on how to apply for an exceptional use authorisation to place medical devices on the UK market. See guidance for further information.

Pricing

UK

• The Department of Health and Social Care (DHSC) has proposed a review of the statutory scheme for branded medicine pricing (VPAG). The consultation document seeks views on the proposals, particularly from the pharmaceutical industry and NHS patients and is open until 25 April 2025. See here for further information including details of the proposals and how to respond to the consultation. See also Association of British Pharmaceutical Association (ABPI) press release

Regulatory

UK

• The MHRA has published guidance on the national assessment procedure for marketing authorisation applications for medicines. See guidance here

Research and Development

UK

• The Health Research Agency (HRA) has published an article to provide clarity on how to determine which projects require review by a Research Ethics Committee. The article provides links to online tools and a detailed published paper with further information. See here for further information.

• DSIT has announced that it will allocate £13.9 billion in funding for transformational research and development in the next year in areas like life sciences, green energy, engineering and beyond. See DSIT press release here and ABPI response to the DSIT allocations here

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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