The workplan will help the regulators 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 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.

·       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.

The BDSG will regularly update the workplan. Stakeholders and other interested parties will be informed and engaged throughout the implementation of the plan.

Related information:

1.    EMA news announcement

2.    Multi-annual AI workplan by the HMA/EMA Big Data Steering Group 

3.    Public consultation on the AI reflection paper is open until 31 December 2023.