Artificial Intelligence 

UK 

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an AI Airlock, its new regulatory sandbox for AI as a medical device, to address challenges for regulating standalone AI medical devices. For further information see MHRA press release. For information on how to get involved in the AI Airlock see here . 

Clinical Trials 

EU 

  • EFPIA has published an article setting out its vision for advancing clinical trials for European patients. See here for further information  

Collaborative Working 

EU 

  • The European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) have published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU). See EMA Press Release on the One Health Framework. 

Data Privacy 

UK 

  • The Information Commissioner’s Office (ICO) calls for organisations to do more to boost their cyber security and protect personal information. See ICO statement for more information. 

 

  • The Information Commissioner has delivered a speech on how the ICO applies the law to emerging technologies. See further details here 

Health Data 

EU 

  • The European Medicines Agency (EMA) has opened a consultation on the use of real-world data in non-interventional studies to generate real-world evidence. The consultation is open until 31 August 2024. For further information see here 

Health Technology Assessment 

EU 

  • EFPIA has published a blog on patient involvement in HTA. For further information see here 

Intellectual Property 

EU 

  • EFPIA raises concerns about EU Commission proposal for a regulation on EU compulsory licensing for crisis management, stating that it believes the initiative will “undermine innovation and competitiveness of European companies, ultimately impeding Europe’s ability to tackle future crises effectively.” See EFPIA statement for further information. 

Medical Devices 

UK 

  • The MHRA has updated the guidance medical devices: the regulations and how we enforce them to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers. For further information see here 

 

  • The first work package in the MHRA and NICE partnership aimed at addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) has concluded. For further information on the findings see here 

Supply 

EU 

  • The European Commission has announced a consultation conference: EU guidance on public procurement of medicines. The event is planned for 23 May 2024. For further details of the agenda and registration see here 

Veterinary Medicines 

UK 

  • On 17th May 2024 the new Veterinary Medicines (Amendment etc.) Regulations 2024 came into force, making changes to the Veterinary Medicines Regulations 2013. The Veterinary Medicines Regulations set out the controls on the marketing, manufacture, distribution, possession, and administration of veterinary medicines and medicated feed. The new Regulations represent the biggest change to the legislation on veterinary medicines since 2013. The UK government has published updated guidance that reflects the changes. For further information see the Veterinary Medicines Directorate Information Hub . You can find a copy of the new legislation here.  

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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