EMA: Draft guideline on regulatory acceptance of 3R (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 animal use and current or future implementation of 3R testing approaches for quality, non-clinical (human) and safety and efficacy (veterinary) testing.