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

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 implementation of 3Rs principles in this context.

Further information on current or future implementation of specific 3Rs testing approaches for human and veterinary medicinal products can be found in separate reflection papers providing an overview of the current regulatory testing requirements for medicinal products for human and veterinary use and opportunities for implementation of the 3Rs. Regulatory acceptance is defined and guidance is given on the scientific and technical criteria for regulatory acceptance of 3Rs testing approaches. Pathways for regulatory acceptance of 3Rs testing approaches are described and procedures for submission and evaluation of a proposal for regulatory acceptance of 3Rs testing approaches are described.