The role of artificial intelligence (AI) is rapidly expanding in the regulatory field, as acknowledged by the new plans published by EMA and the Heads of Medicines Agencies (HMAs) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the EU, the AI workplan to 2028 prepared under the joint HMA-EMA Big Data Steering Group will support the European medicines regulatory network (EMRN) in the use of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making.

At the level of guidance, the public consultation on EMA’s AI reflection paper, closed at the end of December 2023, and it should be followed in 2024 by preparations to support the implementation of the EU AI Act. The plan also aims to identify and provide a framework across the network for the use of AI tools. Training shall be also provided, and the fundamental role of experimentation in accelerating learning and gaining new insights should be valued. In the UK, MHRA’s regulatory roadmap for new regulations aims to support the safe access to transformative medical technologies, such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. The new Statutory Instruments (SIs), which are part of the roadmap, are expected to support the delivery of effective regulation and greater international harmonisation.

Source: EMA, MHRA