This report is aimed at informing pharmaceutical companies and the public of the EMA activities in relation to “3Rs” (replacement, reduction, refinement) during 2016 and 2017. The report summarises the recommendations developed and the organisational structure enabling the development of such guidance. It also looks into the future with details about a new mandate to continue providing advice and recommendations to the Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP) on all matters relating to the use of animals and the application of the ‘3Rs’ principles in the testing of medicines for regulatory purposes. In the reporting period, the working group established for this purpose reviewed animal tests included in product release specifications for centrally authorised veterinary vaccines and human vaccines/biologicals to ensure best practice in 3Rs is applied to the methodology for conducting any in vivo tests. Where potential opportunities for improving compliance with best practice in 3Rs have been identified, the relevant Marketing Authorisation Holders were notified. At the same time, the group consulted with stakeholders on guidance and other 3Rs initiatives and provided expert input on 3Rs regulatory issues associated with medicinal products. The period 2018 – 2019 poses some specific challenges resulting from Brexit and the associated move of the Agency to Amsterdam. Inevitably the focus will be on core-business activities during the period of transition. However, the 3Rs will continue to be addressed, not least through the continued endeavour of the working parties and committees to implement the 3Rs principles without putting public health and animal welfare at risk.
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