8th May 2026 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Theramex HQ UK Ltd has breached clauses 2, 5.1, 6.1, 11.2, 12.1 and 12.9 of the ABPI Code of Practice and has received a public reprimand. Theramex has notified the PMCPA that it no longer accepts the jurisdiction of the PMCPA and has left self-regulation. See CASE/0265/08/24 and CASE/0303/09/24 for further information.

Artificial Intelligence (AI)

EU

• The European Commission is making €63.2 million available to support AI innovation in health and online safety projects. See here for further information.

UK

• • The Secretary of State has enacted the Data Protection Act 2018 (Code of Practice on Artificial Intelligence and Automated Decision-Making) Regulations 2026 (SI 2026/425), effective 12 May 2026. The legislation mandates the Information Commissioner’s Office (ICO) to create a statutory code of practice on AI and automated decision-making under the UK GDPR. The aim of the code will be to provide practical guidance on transparency, explainability, bias mitigation and rights regarding AI-driven decisions. See here for further information.
  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published its latest guest blog on How to seize the growing opportunities of AI and technology ahead
  • The UK government is backing the Sovereign AI fund offering grants of £1million to £9 million to fund the creation of strategic AI assets. Sovereign AI will invest directly in the UK’s most promising AI startups, help them scale and give them support to enable them to compete. See here and here for further information.
  • The MHRA is hosting a live event “Ask me Anything on how artificial intelligence is being regulated in healthcare”. The event will allow interested parties to hear directly from the National AI Commission and ask questions. The event is taking place on 20^th May. See here for further information, including how to register for the event.

   

Clinical Trials

UK

• • The updated Clinical Trials Regulations, which introduce a significant new package of reforms, came into force on 28 April 2026. See MHRA press release and HRA press release for further information. For details of all the guidance published by the MHRA on the new Clinical Trials Regulations, see here
  • The MHRA has published guidance on Clinical trials for medicines: roles and responsibilities, providing information on which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities. See here for further information.
  • The government has published the latest UK clinical research delivery key performance indicators, which show the average time to set up a commercial interventional clinical trial has fallen from 169 days to 122 days. See DHSC press release and HRA press release for further information.
  • The Health Research Authority (HRA) has published new transparency data on UK clinical trials. See here for further information including what the data shows.

   

Data Privacy

EU

• • The European Data Protection Board (EDPB) has published a Guideline on processing of personal data for scientific research purposes and has opened a public consultation on the Guideline. The consultation is open until 25 June 2026. See here and here for further information, the Guideline and how to contribute to the consultation.
  • The EDPB has adopted a Data Protection Impact Assessment template and opened a public consultation on the template. The consultation is open until 9^th June 2026. See here and here for further information, the template and how to contribute to the consultation.

  Competition Law

EU

• The European Commission has adopted a revised Technology Transfer Block Exemption Regulation (TTBER) and Guidelines, which came into force on 1 May 2026. See here for the revised TTBER and Guidelines and further information.

UK

• • The Competition and Markets Authority (CMA) is consulting on updates to its general guidance on transparency and disclosure. The consultation is open until 22 May 2026. See here for further information on the consultation and how to contribute.
  • The CMA has published its case timetable for its strategic review of markets remedies (including the pharmaceuticals market sector). See here for further information.

   

Health Data

EU

• The European Commission has published a draft regulation for dataset descriptions under the European Health Data Space. The aim is to standardise dataset catalogues across Member States. The consultation is open until 12 May 2026. See here for further information including how to contribute to the consultation.

Market Access

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an article exploring the divide between Western Europe and Central and Eastern Europe in access to medicines. See here for further information.

Investment

UK

• • The government’s Life Sciences Innovative Manufacturing Fund is making three new investments into the life sciences sector worth £80 million. See Department for Science, Innovation and Technology (DSIT) press release for further information.
  • DSIT and the Office for Life Sciences have published findings from the early-stage evaluation of the Medicines and Diagnostics Manufacturing Transformation Fund and its successor, The Life Sciences Innovative Manufacturing Fund. For further information and details of the evaluation, see here

   

Policy, Strategy and Trade

UK

• • The Department for Health and Social Care (DHSC) has published a renewed Women’s Health Strategy for England. See Policy Paper and press release for further information.
  • The National Cancer Plan for England, first published in February this year has been updated following an extensive call for evidence exercise. See here for further information.
  • The Life Sciences Healthcare Goals, published in December 2024, have been updated. See here for further information.

   

Regulatory

UK

• The government’s Regulatory Innovation Office through the Front Door pilot is inviting businesses in the science and technology sectors to inform them about regulatory barriers affecting businesses in the sector. The Front Door is an experimental, business led pilot to collect and address regulatory challenges. This phase of the pilot will run to 19 June 2026. See here for further information.

Veterinary Medicines

UK

• The European Medicines Agency (EMA) has published a draft concept paper for consultation on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products. The consultation is open until 31 July 2026. See here for further information, including how to contribute to the consultation.