Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline

This guideline applies to human and veterinary medicines.

This document describes the process for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches for use in the development and quality control during production of human and veterinary medicinal products. It also presents the scientific and technical criteria for validation of 3R testing approaches and explains the pathways for regulatory acceptance of 3R testing approaches.

Keywords: 3Rs, regulatory acceptance, testing approaches, non-clinical, quality, human medicinal products, veterinary medicinal products, qualification, validation, replacement, reduction, refinement

Current effective version

Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches

Adopted Reference Number: EMA/CHMP/CVMP/JEG-3Rs/450091/2012 Summary:

This guideline applies to human and veterinary medicines.

Concept paper

Concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches

Draft: consultation closed Consultation dates: 20/11/2023 to 28/02/2024 Reference Number: EMA/CHMP/CVMP/452614/2023 Summary:

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

Comments should be provided using this EU Survey. 

Document history - First version (current)

Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches

Adopted Reference Number: EMA/CHMP/CVMP/JEG-3Rs/450091/2012 Summary:

This guideline applies to human and veterinary medicines.

Overview of comments received on ' Guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches' (EMA/CHMP/CVMP/JEG-3Rs/450091/2012)

Reference Number: EMA/CHMP/CVMP/JEG-3Rs/25975/2015

Draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches

Draft: consultation closed Consultation dates: 03/10/2014 to 31/12/2014 Reference Number: EMA/CHMP/CVMP/JEG-3Rs/450091/2012 Summary:

In accordance with Directive 2010/63/EU, the principle of the 3Rs (replacement, reduction and refinement) needs to be considered when selecting testing approaches to be used for regulatory testing of human and veterinary medicinal products. A general overview is provided on animal use and current or future implementation of 3R testing approaches for quality, non-clinical (human) and safety and efficacy (veterinary) testing.

Concept paper on the need for revision of the position on the replacement of animal studies by in vitro models

Draft: consultation closed Consultation dates: 17/03/2011 to 30/06/2011 Reference Number: EMA/CHMP/SWP/169839/2011 Summary:

The proposed Guideline will replace the Position on Replacement of Animal Studies by in vitro Methods (CPMP/SWP/728/95).

Document history - Superseded document

Replacement of animal studies by in vitro models

Adopted Reference Number: CPMP/SWP/728/95