Artificial Intelligence 

EU 
  • The EMA and Heads of Medicines Agencies have published a workplan to guide the use of AI in medicines regulation. The workplan focuses on four key area: i) Guidance, policy and product support; ii) AI tools and technology; iii) Collaboration and training and iv) Experimentation. The EMA announcement and Workplan are available here  

Borderline Products 

UK 
  • The MHRA has published its final determinations on borderline products to December 2023. See final determinations here and wider guidance on borderline products here 

  Data Privacy 

EU 
  • The European Commission has called for feedback on how the European Data Protection Regulation is working. The feedback period is open from 11th January until 8th February 2024. For further information on this initiative and how to provide feedback see here 
France 
  • The French data protection authority has issued guidance on health data processing and storage standards. The guidance highlights the importance of compliance with the EU General Data Protection Regulation and highlights additional measures to ensure health data is protected. See guidance here 
  UK 
  • The Information Commissioner has launched a consultation series on generative AI, which will look at how data protection law should apply to the development and use of the technology. The consultation closes on 1st March 2024. See press release and further details of this consultation (including how to respond) as well as the wider consultation series here 
  • The Information Commissioner has now made public its cookie deficiencies letter, sent to the UK’s top websites in November 2023, with a view to helping other sites achieve compliance. The letter provides helpful guidance. See cookie deficiencies letter 

German Pharmaceutical strategy 

  • The German Federal Government published its strategy paper on 13th December 2023, setting out its goals to strengthen Germany as a centre for research and pharmaceutical innovation. The strategy paper covers a number of important areas, including strengthening clinical research, incentivising investment in manufacturing and diversifying supply chains, advancing healthcare digitalisation and implementing a German health data space, strengthening regulatory authorities and consolidating responsibilities, creating a regulatory framework to ensure EU market competitiveness and protecting proprietary clinical data and intellectual property. It also covers proposals for the promotion of innovation and research projects, stabilisation of the German statutory health insurance system as well as reduction in bureaucracy. For further information and to access the strategy paper see here 

Marketing Authorisations 

EU 
  • EMA January issue of human medicine highlights which contains information on CHMP opinions and new medicine approvals can be accessed here 
UK 
  • The MHRA is to share drug filing information with the NHS and other health system partners. See the Operational Information Sharing Guidance, which includes details of the information sharing process and information shared.  
  • Project Orbis is a programme to review and approve cancer drugs to facilitate faster access to treatments. The MHRA updated its guidance in relation to Project Orbis and ILAP and has removed the requirement to obtain an innovation passport as part of Project Orbis. See further information here 
  • From 1st January 2024 the MHRA’s new International Recognition Procedure (IRP) comes into effect. This is a recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Switzerland, Singapore and the United States. The new framework allows access to medicines which have already been approved by trusted regulatory authorities and sits alongside the MHRA’s current national procedures. For further information and guidance on the IRP see here 

Market Access 

UK 

Medical Devices 

UK 
  • The MHRA has published its regulatory roadmap towards the future regulatory framework for medical devices, which provides clarity on the way ahead for implementation of the future core regulations covering medical technology, AI and diagnostics. See information on the implementation of medical devices future regime and the Roadmap here and the MHRA press release here 

Packaging and Labelling 

UK 
  • The guidance information on the packaging and labelling of medicinal products for human use following agreement on the Windsor Framework has been updated. Please see further information on the guidance and updates here 

 Pricing 

UK 
  • The full text of the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG) has been published by the Department of Health and Social Care (DHSC). Suppliers of branded medicines have an extended deadline of 15th January 2024 to decide whether to join the 2024 Voluntary Scheme or defer to the Statutory Scheme. See further information and VPAG full text here 

Procurement 

UK 
  • The new Provider Selection Regime (PSR) came into force on 1st January 2024 and sets out rules for the procurement of health care services in England by organisations termed ‘relevant authorities’ (including the NHS, integrated care boards, NHS trusts and NHS foundation trusts). The PSR does not apply to the procurement of goods or non-healthcare services (unless mixed procurement). See further information on the PSR here