Artificial Intelligence

EU

  • The Corrigendum of the EU AI Act has now been released. The document corrects and clarifies the text and is required before the Act comes into effect. See the corrected text here

France

  • The French data protection authority, CNIL, has issued its recommendations for using artificial intelligence technologies whilst protecting personal data. See CNIL recommendations

UK

  • The UK Information Commissioner’s Office (ICO) has launched a further instalment of its consultation series examining how data protection law applies to the development and use of generative AI. The third consultation seeks views on the accuracy of generative AI models. The consultation is open until 5 pm on 10th May 2024. Further information is available here

Clinical Trials

UK

  • The UK Health Research Authority (HRA) is consulting on a new Model Investigator-Initiated Study Agreement and has published a model agreement for comment. The HRA is calling for comments on the draft agreement by 13 May 2024. For further information on the consultation and draft agreement see here

Collaborative Working

UK

  • The NHS Confederation, ABPI and health industry and charity leaders have produced a report setting out insights on how to maximise the potential for collaboration between the NHS, health charities and the life sciences industry to boost research and innovation. See report for further information.

Data Privacy

EU

  • The European Data Protection Board (EDPB) has set out its strategy and priorities for 2024-2027. For further information and details of the strategy see EDPB press release

UK

  • The UK ICO has published guidance to help health and social care organisations ensure they are being transparent with people about how their personal data is used. See press release and guidance for further information.

Health Data

EU

  • The European Medicines Agency (EMA) has issued guidance setting out how its real-world evidence generation services can be used. See guidance for further information.

Health Technology Assessments

EU

  • The life sciences industry has expressed concerns over the workability of the new EU HTA procedure. See EFPIA statement and information on the implementation of the Regulation on health technology assessment here

Importation

UK

  • The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on UK parallel import licences following agreement of the Windsor Framework. See guidance and further information

Marketing Authorisations

EU

  • The EMA April issue of human medicine highlights which contains information on CHMP opinions and new medicine approvals can be accessed here

Pharmaceutical Law Reforms

EU

  • The European Parliament has adopted its position on the Commission proposal to reform EU pharmaceutical legislation following political disagreement. For further information on the texts adopted see here and here.
  • EFPIA has responded to the European Parliament plenary vote on the EU pharmaceutical legislation reform proposal, noting improvement to the Commission proposal, but remaining concerned about European competitiveness. See EFPIA statement

Regulatory

EU

  • The European pharmaceutical industry has come together with a view to improving the content of medicinal product patient information leaflets, prioritising patient needs. For further information see recommendations and EFPIA statement

UK

  • The MHRA has launched a service (RegulatoryConnect) that provides the capability to track applications and view live authorisation details. 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.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.