EMA researchers map AI research priorities across the medicines lifecycle
Decision brief
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EMA researchers and collaborators ran a survey to identify priority research areas for AI across the medicines lifecycle, from development to post-authorization monitoring. The top priority across all groups was accuracy and reliability of AI tools.
Key questions this brief answers
- Does EMA use AI?
- What is data and AI in medicines regulation to 2028?
- What are the future trends in regulatory affairs?
- What did the EMA identify as the top AI research priority?
EMA researchers and collaborators ran a survey to identify priority research areas for AI across the medicines lifecycle, from development to post-authorization monitoring. The top priority across all groups was accuracy and reliability of AI tools.
Contents8 sections
EMA researchers map AI research priorities across medicines lifecycle
Key Takeaways
- Accuracy and reliability of AI tools ranked as the highest research priority, according to EMA-led findings on regulatory research priorities for AI.
- The EMA has extended its AI-enabled Scientific Explorer tool to help regulators and national competent authorities retrieve information related to initial marketing authorisation applications for human medicines.
- The Data and AI in medicines regulation to 2028 plan sets a five-year framework for how European regulators will manage, analyze, and share health data to support research, improve interoperability, and enable more timely authorization of medicines.
- Future regulatory affairs trends point toward big data, AI, and machine learning in regulatory processes to enable real-time regulation.
EMA and collaborators identified AI research priorities across the medicines lifecycle
The European Medicines Agency and its collaborators ran a survey to identify priority research areas for artificial intelligence across the medicines lifecycle. According to the research published in the RAPS journal of regulatory affairs, accuracy and reliability of AI tools emerged as the highest priority across all groups by a substantial margin.
The survey covered research needs spanning product development through post-authorization monitoring and evaluation. The identification of these priorities signals where the EMA and its partners see the greatest need for evidence and methodological development as AI applications expand across regulatory processes.
EMA's Scientific Explorer shows current AI use in regulatory work
The EMA has already deployed AI tools in its regulatory operations. The agency extended the functionality of its AI-enabled knowledge mining tool, Scientific Explorer, to support EMA and national competent authorities in finding information related to initial marketing authorisation applications for human medicines.
This tool represents the EMA's current operational use of AI in regulatory work, even as the agency continues to research best practices for accuracy and reliability across the broader regulatory lifecycle.
The 2028 data and AI plan defines the regulator's longer-term framework
The EMA and Heads of Medicines Agencies (HMA) have jointly published a five-year plan titled Data and AI in medicines regulation to 2028. The plan outlines how European regulators will manage, analyze, and share regulatory and health data to support research, improve interoperability, and enable more timely authorization of medicines.
Future regulatory affairs trends point toward big data, AI, and machine learning
Broader trends in the regulatory affairs profession increasingly emphasize advanced technologies in core regulatory processes. Research on future directions in regulatory affairs identifies big data, artificial intelligence, and machine learning as key trends in regulatory processes, with a particular focus on enabling real-time regulation.
Frequently Asked Questions
Does EMA use AI?
Yes. The EMA has extended its AI-enabled Scientific Explorer tool to help EMA and national competent authorities find information related to initial marketing authorisation applications for human medicines.
What is data and AI in medicines regulation to 2028?
It is a five-year plan published jointly by the EMA and Heads of Medicines Agencies that describes how regulators will manage, analyze, and share regulatory and health data to support research, improve interoperability, and enable more timely authorization of medicines.
What are the future trends in regulatory affairs?
Research on future directions in regulatory affairs identifies big data, artificial intelligence, and machine learning as key trends in regulatory processes, with emphasis on enabling real-time regulation.
What did the EMA identify as the top AI research priority?
Accuracy and reliability of AI tools ranked as the highest research priority in the EMA-led research on regulatory priorities for AI across the medicines lifecycle.
