Annex 22: Results of the EMA Workshop
On 30 June, the EMA’s Annex 22 Working Group discussed the future scope of the annex with AI experts and representatives of the pharmaceutical industry (as previously reported).
The workshop provided valuable expert input to support the ongoing development of Annex 22. Industry associations expressed broadly aligned views on the six discussion topics. While acknowledging the challenges associated with adaptive, probabilistic and generative AI systems, they consistently advocated a risk-based, technology-neutral approach. The acceptability of an AI application, they argued, should be determined not by the underlying technology itself, but by its intended use, the associated risks and the effectiveness of control measures throughout its lifecycle.
The following points were consistently identified as important prerequisites:
- Documented intended use
- Robust quality risk management
- Validation and monitoring throughout the lifecycle
- Human oversight proportionate to risk
- Effective control mechanisms
- Clear accountability
- Supplier oversight
- Maintenance of a demonstrable state of control
Existing GMP principles, particularly those relating to quality risk management, validation, lifecycle management, monitoring and outsourced activities, remain relevant and applicable to AI systems.
Additional clarification, definitions or AI-specific expectations may be required in various areas to ensure that Annex 22 provides a practical and scientifically sound framework for the use of increasingly sophisticated AI technologies in the GMP environment.
Overall, the workshop achieved its aim: structured, experience-based input from industry on the governance, control, validation and monitoring of AI systems provided the Working Group with valuable insights to support the further development of Annex 22.
What happens next?
The information presented at the workshop will be carefully reviewed by the Annex 22 Working Group. This review will also consider the common approaches, differing views and challenges identified during discussions across the six topic areas. The outcomes of these discussions will feed into the ongoing revision of Annex 22. The aim is to develop a scientifically sound, risk-proportionate and practical framework for the use of AI in GMP-regulated environments. The revised guidance should strike an appropriate balance between protecting product quality and patient safety on the one hand and recognising the potential benefits of technological innovation on the other. .
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