The EMA and the Heads of Medicines Agencies (HMA) have published a ‘multi-annual AI workplan 2023-2028’ to facilitate the safe and effective use of artificial intelligence (AI) for the benefit of human and animal health.

The workplan, prepared under the joint HMA-EMA Big Data Steering Group (BDSG), was adopted by the EMA’s management board at its December meeting. It focuses on four key areas to ensure the ‘beneficial and responsible’ use of AI: guidance, policy and product support, tools and technologies, collaboration and change management, and experimentation.

Key milestones outlined in the workplan include the development of AI guidance in the medicines lifecycle (in collaboration with the Committee for Medicinal Products for Human Use’s (CMHP) Methodology Working Party) including domain-specific indications, such as pharmacovigilance. Also outlined was the deployment of large language models including chatbots to increase office productivity.

This development was discussed at length at the EMA’s Third Veterinary Big Data Stakeholder Forum, in November last year. Lastly, implementing AI workshops to keep both the European medicines regulatory network, as well as the public, up to date in the rapidly evolving field.

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The pharmaceutical sector is increasing its use of AI-powered tools to spur research, development and access to medicines. Indeed, the National Institute for Health and Care Excellence (NICE) approved nine artificial intelligence technologies last year to aid in radiotherapy contouring.

While the EMA and HMA look to embrace the opportunities of AI, they recognise its ethical and policy risks. In a statement the agencies said: “The use of AI will require constant monitoring, both of the impact of AI as well as the emergence of novel systems and approaches”.

Aware of the constantly evolving nature of the AI field, they said that regulators, medicine developers, academics, patient organisations and other interested parties will be informed and engaged throughout the implementation of the plan.


Further reading:

EMA-HMA: Multi-annual AI workplan 2023-2028

Regulatory Rapporteur: Safe use of AI is subject of EMA reflection paper

Regulatory Rapporteur: FDA to establish digital health advisory committee