21st November 2025 Update

Animal Testing

UK

• The government has set out a new strategy to replace the use of animal testing in science and to support the development, validation and uptake of alternative methods. See here for further information.

Artificial Intelligence (AI)

EU

• The European Parliament’s EMPL committee has outlined a draft agenda to address the impact of AI on the workplace and proposes a law to regulate the use of algorithmic technologies, including AI. The request for a legislative initiative was adopted. See the European Parliament press release for further information.
• The European Commission has published its new digital package, which includes its Digital Omnibus, a proposal aimed at simplifying AI, data protection, cybersecurity and data use as well as introducing a single point of entry for incident reporting. See European Commission press release for information and details of the legislative proposals, including Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation proposal

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published a guest blog by Professor Alastair Denniston on the future regulation of AI in healthcare. See here for further information.

Clinical Trials

EU

• The European Medicines Agency (EMA) has published a draft guideline on non-inferiority and equivalence comparisons in clinical trials and is seeking feedback on the guideline. The consultation is open until 31 May 2026. See here for further information including how to provide feedback.

UK

• The Health Research Authority (HRA) is requesting feedback on proposed changes to the model Clinical Trial Agreement and the related suite of commercial agreements. See HRA press release for more information, including details of planned changes and how to provide feedback. Comments are welcome until 30 November 2025.

Competition Law

EU

• The European Commission has published a policy brief regarding the scope of legal professional privilege, including whether the position of in-house lawyers has changed. The paper concludes that extending legal professional privilege to in-house lawyers would not be justified from the perspectives of EU law or of enforcement policy. See here for further information.

Data Privacy

EU

• The European Data Protection Board (EDPB) is holding a stakeholder event on anonymisation and pseudonymisation where it will also look at the implications of the Court of Justice of the European Union (CJEU) judgement in EDPS v Single Resolution Board. The event is taking place on 12 December 2025 and further information on the event including how to register is available here
• The EDPB is developing a series of ready-to-use templates with the aim of providing practical tools for organisations to implement, to meet their data protection obligations. The EDPB has launched a public consultation on the templates and contributions can be submitted until 3 December 2025. For further information including how to contribute, see here.

EU Biotech Act

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Vaccines Europe have called for clear and predictable legislation under the proposed EU Biotech Act to boost Europe’s competitiveness and ensure Europe is an innovation-friendly environment for biotechnology. EFPIA has responded to the European Commission’s public consultation. See here for EFPIA press release and consultation response.

Market Access

UK

• The Association of the British Pharmaceutical Industry (ABPI) and the government have agreed a further extension to the deadline by which companies must give notice if they intend to leave the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). The deadline is now extended until 16 December 2025. See ABPI press release for further information.

Medical Devices

UK

• The MHRA has published a report on attitudes identifying and reporting harms associated with the use of digital mental health technology and awareness of the MHRA yellow card scheme. See here for further information.

Regulatory

EU

• The EMA has published a new process outlining an improved approach to scientific advice for the most promising medicines and vaccines under development for public health threats. See EMA press release and guidance for further information.
• The EMA has published its Human Medicines Highlights for November with information on new medicines recommended for approval and CHMP opinions. See here for further information.

UK

• The MHRA has published a consultation to gather feedback on International Council for Harmonisation Guideline Q3E for Extractables and Leachables. The consultation is open until 19 January 2026. See here for further information including how to provide feedback.

Strategy Policy and Trade

UK

• The ABPI has used its pre-budget submission to put pressure on the government to reverse the decline in investment in the life sciences sector in the UK and improve competitiveness. See ABPI press release and pre-budget submission here
• The Life Sciences Strategy for Scotland for the next ten years has been published, aimed at accelerating growth and driving innovation. See here for further information.
• The UK government has announced that it is awarding more than £54 million across eight innovative R&D projects through the Sustainable Medicines Manufacturing Innovation Programme. See UK government press release for further information.