The principle of Replacement, Reduction and Refinement of animal testing in the development of medicines (known as the 3Rs) refers to the replacement of animal studies with non-animal methods, the reduction of animal studies, and the refinement of any necessary tests through minimisation of stress of study animals (as illustrated in the graphic below). Under European law, all EU Member States must ensure that the 3Rs are systematically considered whenever animals are used for scientific purposes, including research, regulatory testing and production, education and training (see Directive 2010/63/EC on the protection of animals used for scientific purposes). On 26 February 2018, the European Medicines Agency (EMA) issued a Report summarising its activities during 2016 and 2017 in relation to the 3Rs in the regulatory testing of medicinal products.

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