Submission of comments on the Concept paper on the revision of the Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches is now open.

This Guideline was adopted in 2016 with the aim to encourage stakeholders and authorities to initiate, support and accept development and use of 3Rs testing approaches to replace, reduce and refine in vivo animal studies for human and veterinary medicinal products.

Since its implementation, scientific, technological and regulatory knowledge on 3R testing approaches, such as microphysiological systems, including organ-on-chip models, has significantly evolved. Consequently, there is a need for more specific guidance to assist in the development and potential regulatory use of these New Approach Methodologies.

In addition, the most important 3Rs-related terms should be defined to act as the basis for the drafting of EMA documents in the field of New Approach Methodologies and to fully inform all involved stakeholders. This will be expanded upon in a new dedicated section in the guideline.

Comments should be provided by 28 February 2024 by using this EU survey.