Advertising

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published decisions for December 2024 made by the MHRA following investigations into complaints about advertising for licensed medicines. See here for further information.

Artificial Intelligence

EU

  • The European Commission has released the second draft of the General-Purpose AI Code of Practice. See here for further information.

USA

  • The United Staes Federal Drug Agency (FDA) has issued draft guidance on the use of artificial intelligence (AI) for the development of drug and biological products. For further information see FDA press release

Brexit

UK

  • The MHRA has published supplementary Information for pharmaceutical wholesalers explaining the main changes the Windsor Framework introduces to the packaging for all medicines licensed in the UK, effective from 1 January 2025. See here for further information.
  • The MHRA has published supplementary information for pharmacists and medicines procurers explaining the main changes the Windsor Framework introduces to the packaging for all medicines licensed in the UK, effective from 1 January 2025. See here for further information.

Competition Law

US/Switzerland

  • Sandoz has agreed to pay another $275 million to settle claims it engaged in price-fixing in the generic drug industry. See here for further information.

Data Privacy

EU

  • The European Data Protection Board (EDPB) has adopted guidelines on pseudonymisation. See Guidelines and EDPB press release for further information.
  • The EDPB has issued an Opinion on the use of personal data for the development and deployment of AI models. See Opinion and EDPB press release for further information.

UK

  • The Information Commissioner’s Office (ICO) has announced plans to tackle cookie compliance across the UK’s top 1000 websites. See ICO press release for further information.

Health Data

EU

  • The Council of the European Union has adopted the European Health Data Space (EHDS) Regulation, which aims to make it easier to exchange and access health data at EU level. For further information see Council of the EU press release

Intellectual Property

UK

  • The UK Intellectual Property Office (IPO) has opened a consultation on proposals to give creative industries and AI developers clarity over copyright laws. The consultation is open until 25 February 2025. For further information including how to provide feedback see consultation information and IPO press release
  • The UK IPO has published the most recent updates to the Manual of Patent Practice. See IPO press release for further information.

Market Access

EU

  • On 12 January 2025 the EU Health Technology Assessment Regulation (HTAR) entered into force, introducing centralised assessment of clinical evidence at EU level for new EMA filings for oncology products and ATMPs. The next implementation phase will start in 2028 for orphan drugs and 2030 for all products. See European Commission press release for further information.

UK

  • The Association of the British Pharmaceutical Industry (ABPI) has posted an interesting Blog article on improving patient access to innovative medicines. See ABPI article here

Medical Devices

UK

  • The MHRA has published a suite of guidance designed to help medical device manufacturers understand and prepare for the new Post-market Surveillance (PMS) Regulation. See MHRA press release and guidance for further information.

Packaging

UK

  • The MHRA has published Guidance for international regulators explaining the changes to the packaging for all medicines licensed in the UK, effective from 1 January 2025. See Guidance for further information.

Pharmacovigilance

EU

  • On 18 December 2024 the European Commission published a proposed implementing regulation relating to pharmacovigilance requirements for human medicines marketed in the EU. See draft implementing regulation and feedback from consultation here

Regulatory

EU

  • The European Medicines Agency (EMA) has published its Human Medicines Highlights for January with new information on approved medicines and new medicines recommended for approval. See here for further information.
  • EMA has published a report, following a pilot, exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures. The pilot found that the EU regulatory system is generally prepared for the introduction of ePI and can move towards its phased implementation in regulatory procedures. For more information, see EMA press release and See also article published by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Research and Development

UK

  • The MHRA has announced a public Consultation on the International Council for Harmonisation ICH M15 Guideline for Model Informed Drug Development (MIDD). The Consultation is open until 31 March 2025. See here for further information.

Transparency

EU

  • EMA and the Heads of Medicines Agencies (HMA) have published a thorough overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications, reaffirming their commitment to extensive transparency when disclosing information. See EMA press release and guidance 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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