28th April 2025 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has published a ruling in CASE/0244/07/24 advising that GSK has brought discredit upon the pharmaceutical industry for producing prescribing information which was misleading. See case report for further information.

Artificial Intelligence (AI)

EU

• The European Commission has published a multi-stakeholder consultation to clarify the scope of the general-purpose AI rules in the AI Act. For further information on the consultation see here and here. The consultation is open until 22 May 2025.

• The European Commission has opened a call for evidence on a European strategy for AI in science. The Call for Evidence is open until 5 June 2025. See here and here for further information.

Clinical Trials

UK

• The Health Research Authority (HRA) has published its annual report on the registration status of clinical trials in the UK. See HRA press release for further information and a copy of the full report.

Intellectual Property

UK

• The UK Government has published its response to the second transformation consultation. See Intellectual Property Office press release for further information.

Policy and Strategy

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its submission on the call for evidence on the new Strategy for European Life Sciences. See EFPIA press release for further information.

Global

• The Biopharmaceutical CEO Roundtable, representing the world’s leading biopharmaceutical companies met in London on 4th April to discuss strengthening global health policies and frameworks to drive innovation. See International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) press release for further information.

Quality

International

• The International Council for Harmonisation (ICH) has updated its guideline on stability testing of drug substances and drug products by consolidating and modernising its existing stability guidelines. The guideline has been issued to regulatory members for public consultation. See here for further information.

Regulatory

EU

• The European Medicines Agency (EMA) has published its Human Medicines Highlights for April 2025, including information on new medicines and CHMP Opinions. See here for further information.

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published Guidance for healthcare professionals on risk minimisation options for medicines. The Guidance is aimed at facilitating the safe and effective use of medicines by healthcare professionals, patients and carers. See MHRA press release 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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