Plan for the Implementation of Artificial Intelligence to Direct its Application in Medicine Regulation

EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.

Fri Dec 22, 2023

The European Medicines Regulatory Network (EMRN) is poised to leverage the potential of Artificial Intelligence (AI) through a strategic workplan. This plan, developed in collaboration with the HMA-EMA Big Data Steering Group, is designed to enhance personal productivity, automate processes, and elevate data insights for more informed decision-making. By embracing AI, the EMRN aims to stay at the forefront of innovation in medicines regulation. The rapid evolution of AI in pharmaceuticals necessitates proactive measures, and this workplan, endorsed by EMA's Management Board, is a response to the swift integration of AI-powered tools in pharmaceutical research, development, and monitoring. The plan prioritizes four key dimensions to ensure the effective incorporation of AI in the regulatory landscape.

  • Guidance, policy and product support: The efforts concentrate on providing ongoing assistance for products in development and formulating relevant guidance for the application of AI throughout the lifecycle of medicines. Initiatives are already underway, including the ongoing public consultation on the AI reflection paper, which is open for participation until the end of December 2023. Additionally, preparations for supporting the implementation of the EU AI Act will commence in 2024.
  • AI tools and technology: The aim is to identify and provide frameworks across the network to use AI tools to increase efficiency, enhance understanding and analysis of data and support decision-making. Full compliance with data protection legislation will be ensured.
  • Collaboration and training: Initiatives are designed to continuously develop capacity and capability of the network, partners and stakeholders to keep ahead of the evolving field of AI.
  • Experimentation: The workplan acknowledges the fundamental role of experimentation in accelerating learning and gaining new insights. Several actions are proposed to ensure a structured approach to experimentation across the network.

Given the rapid evolution of AI technology, encompassing ethical and policy considerations, the BDSG commits to regularly revising the workplan. Continuous updates will be shared with regulators, medicine developers, academics, patient organizations, and other stakeholders to ensure their informed involvement and engagement throughout the plan's implementation.

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