Europe – Qualification of digital technology-based methodologies to support approval of medicinal products (Questions and Answers)

This document highlights some of the key points to consider for the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.

The principal focus of the document is to support Qualification of methodologies based on digital technologies in the context of medicinal product development. It may also be of assistance to applicants in the preparation for other types of EMA procedures and interactions, such as Innovation Task Force (ITF) meetings, scientific advice briefing books drafting, and preparation of Marketing Authorisation Applications (MAAs).

This Q&A document is not intended to provide comprehensive guidance; instead, it reflects EMA’s current experience at the time of publication. As this is an area of rapid evolution, further considerations may be added as EMA’s experience increases.

Due consideration should be given to general guidance documents on Qualification available on the EMA website1, which is supplemented by this Q&A document focusing on aspects specific to digital technologies…