EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine

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The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

The European Medicines Agency (EMA) published a draft reflecting paper on July 19, 2023 detailing the agency’s current outlook on the use of artificial intelligence (AI) “to support the safe and effective development, regulation and use of human and veterinary medicines.” The paper, now open for public discussion, outlines recommendations for the use of AI and machine learning (ML) during any step of a medicines’ lifestyle, from drug discovery to the post-authorization setting.

“AI and ML tools have the potential to effectively support the acquisition, transformation, analysis, and interpretation of data across the medicinal product lifecycle,” wrote EMA in a press release. “Their application can include, for example, AI/ML modelling approaches to replace, reduce, and refine the use of animal models during the preclinical development.”

During clinical trials, AI/ML systems may also assist with data recording and analyses that can be submitted to regulators in marketing-authorization procedures. During the marketing-authorization stage, AI has tools to draft, compile, translate, or review data that are used in the product information of a medicine. During the post-authorization stage, these tools could potentially support pharmacovigilance activities.

The reflection paper emphasizes that a human-centric approach should be at the forefront of all development and deployment of AI and ML. All use of AI should comply with existing legal requirements and take ethics and the respect of fundamental rights into consideration.


“The use of artificial intelligence is rapidly developing in society, and as regulators, we see more and more applications in the field of medicines. AI brings exciting opportunities to generate new insights and improve processes. To embrace them fully, we will need to be prepared for the regulatory challenges presented by this quickly evolving ecosystem” said Jesper Kjær, director of the Data Analytics Centre at the Danish Medicines Agency and co-chair of the joint HMA-EMA Big Data Steering Group (BDSG), in an EMA press release.

EMA recommends that developers seek early regulatory support for AI/ML systems expected to impact the benefit-risk balance of a medicine. “With this paper, we are opening a dialogue with developers, academics, and other regulators, to discuss ways forward, ensuring that the full potential of these innovations can be realized for the benefit of patients’ and animal health,” said Peter Arlett, EMA’s head of Data Analytics and Methods, co-chair of the BDSG, in an EMA press release.

The paper is part of BDSG initiatives to “to develop the European Medicines Regulatory Network’s capability in data-driven regulation.” It was creative collaboratively by the BDSG, EMA’s Committee for Medicinal Products for Human Use and its Committee for Veterinary Medicinal Products.

All stakeholders are invited to comment on the draft reflection paper. The public consultation will be open until Dec. 31, 2023. The HMA and EMA will hold a joint workshop on Nov. 20–21, 2023 to discuss the topic further.

Source: EMA