This work has been analyzed and disseminated by por Guillem López, CSV & QA Manager at OYTEC, author of the article “The 10 Principles of Pharmaceutical AI according to the EMA and FDA”.
Common Framework, Different Execution
The alignment of criteria between both regulatory agencies aims to guide the use of AI in the pharmaceutical field without hindering innovation. However, when these principles are translated into regulatory draft guidelines, relevant nuances emerge: shared objectives, but different approaches.
These principles are set forth in the joint agency document Guiding Principles of Good AI Practice in Drug Development. They are also reflected in the EMA’s draft Annex 22 and in the FDA’s AI Credibility Framework Guidance.
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