EMA’s Guide: Smoothly Navigating AI in Medical Regulation

The European Medicines Agency (EMA), along with the Heads of Medicines Agencies (HMAs), recently published a strategy outlining the use of artificial intelligence (AI) in medicine regulation. This strategy, known as The Multi-annual AI Workplan 2023–2028, details a plan to utilise the benefits that AI technologies bring to the regulatory system, while mitigating any related risks.

  • The workplan underlines the importance of a concerted approach in applying AI, ensuring a balance between benefits and risks.
  • The plan encompasses crucial elements such as guidance, policy, and product support, AI tools and technology, collaboration and training, and experimentation.

The EMA and HMAs recognise the exponentially advancing nature of AI technology and its associated ethical and policy issues. As such, they will regularly revise the workplan to keep up with the developments and maintain regulatory relevance. The organisations are also committed to engaging with regulators, medicine developers, patient organisations, academics, and other interested parties throughout the plan’s implementation.

  • The plan includes preparations for the implementation of the EU AI Act, slated to commence in 2024.
  • In the realm of AI tools and technology, framework identification and provision for the use of AI tools for data analysis and decision-making are included.
  • The EMA and HMAs also intend to roll out initiatives that enhance the capacity and capability of the European medicines regulatory network.
  • A structured methodology for accelerated AI learning is also proposed as part of the plan’s experimentation element.

The strategy reflects the action-oriented and dynamic approach of the EMA and HMAs in preparing for and navigating the digital disruption brought about by AI technology in the healthcare sector. Despite the potential challenges, the agencies underscore the importance of maximising the benefits of AI and managing the risks associated with its use.