EMA and HMAs Announce 2028 Workplan to Harness Artificial Intelligence in Medicines Regulation

EMA and HMAs Announce 2028 Workplan to Harness Artificial Intelligence in Medicines Regulation

(IN BRIEF) The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have jointly released a comprehensive Artificial Intelligence (AI) workplan outlining their collaborative strategy through 2028. This initiative aims to maximize the benefits of AI for stakeholders while effectively managing associated risks. The workplan is set to empower the European medicines regulatory network (EMRN) by harnessing AI’s potential for enhancing personal productivity, automating processes, gaining deeper insights from data, and facilitating more robust decision-making in the interest of public and animal health. The plan, developed under the HMA-EMA Big Data Steering Group (BDSG), ensures that the EMRN remains at the forefront of AI adoption in medicines regulation. The fast-evolving field of AI, with its impact on pharmaceutical research, development, and monitoring, prompts the need for proactive measures. The workplan focuses on four key dimensions: providing guidance and policy support, advancing AI tools and technology, promoting collaboration and training, and facilitating structured experimentation. Regular updates will be made to the plan, keeping all stakeholders, including regulators, pharmaceutical developers, academics, patient organizations, and others, informed and engaged as AI technology evolves, encompassing ethical and policy considerations.

(PRESS RELEASE) AMSTERDAM, 19-Dec-2023 — /EuropaWire/ — 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.

The workplan will help the European medicines regulatory network (EMRN) to embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

The AI workplan, prepared under the joint HMA-EMA Big Data Steering Group (BDSG), ensures the EMRN remains at the forefront in benefiting from AI in medicines regulation. The workplan was adopted by EMA’s Management Board at its December meeting.

The field of AI is developing swiftly. Pharmaceutical companies increasingly use AI-powered tools in research, development and monitoring of medicines. National competent authorities are responding to the new opportunities and challenges by starting to use and develop AI tools.

The workplan focuses on four key dimensions:

• Guidance, policy and product support: Actions focus on continuous support to products in development as well as the development and evaluation of appropriate guidance for the use of AI in the lifecycle of a medicine. Work has already begun with the ongoing public consultation on the AI reflection paper, open until the end of December 2023. Furthermore, in 2024 preparations to support the implementation of the EU AI Act will start.
• 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.

As AI technology is fast evolving, including the ethical and policy aspects related to it, the BDSG will regularly update the workplan. Regulators, medicine developers, academics, patient organisations and other interested parties will be informed and engaged throughout the implementation of the plan.

Media Contact:

Heads of Medicines Agencies Permanent Secretariat
E-mail: ps@hma.eu

EMA press office
Tel. +31 (0)88 781 8427
E-mail: press@ema.europa.eu

SOURCE: European Medicines Agency