Suggested criteria for using AI/ML algorithms in GxP

08 March 2021

The Danish Medicines Agency (DKMA) is currently working internally, in a European and international context to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across the various GxP-regulated areas. There is nothing in the current legislation that directly addresses the use of AI/ML algorithms and DKMA has therefore written a proposal for criteria and questions that can be expected to be asked for such algorithms.

The proposal applies to static AI/ML algorithms that implement critical GxP-related functions and are trained using supervised learning. The proposal is not intended as a complete set of criteria, more as a, hopefully, mature draft. Comments are very welcome and should be sent by e-mail to Medicines Inspector, GxP IT, Ib Alstrup, no later than 30 April 2021.


Questions to critical GxP AI-ML applications v. 0.9.4 (pdf)