EMA released its action plan for the future-proofing of the qualification of novel methodologies this week

If you remember, EMA has organised a multi-stakeholder workshop on qualification of novel methodologies on 17Apr23. Following the workshop recommendations, an action plan for the future-proofing of the qualification of novel methodologies has been agreed, and was released Wednesday this week.

The Action plan (dated Sep24) is made of 15 pages and cover from 3Q24 to 4Q25. Most of the actions are planned for 2025.

3 topic areas are described:

• General guidance update, templates and lifecycle-management strategy/rules/process
• Methodology specific guidance, QA high-level information publication, external expert involvement
• Procedure/process optimisation, stakeholder communication and engagement

You can download the Action plan directly at: https://www.ema.europa.eu/en/documents/other/future-proofing-qualification-novel-methodologies-qonm-action-plan_en.pdf

or have a look at the workshop page (recording & slides): https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-qualification-novel-methodologies