Ethical considerations in animal experiments

SHIONOGI is consistently working in research and development of innovative and reliable pharmaceutical products on the basis of its company policy of “SHIONOGI strives constantly to supply the best possible medicine to protect the health and wellbeing of the patients we serve”. Predicting safety and efficacy of pharmaceutical product in humans is still an undoubted challenge while trying to solve it by application of current science and technology and thus animal experiments are required for understanding the benefit-risk profile of investigational drugs.

To conduct proper animal experiments in compliance with the internationally recognized principles of the 3Rs (replacement, reduction and refinement) for humane experimentation on animals, SHIONOGI has established its company regulations based on the applicable laws, regulations, guidelines and standards for animal experimentation in Japan and is making its best efforts to ensure ethical use of animals for scientific purpose in accordance with the rule for animal experiment including the Institute for Laboratory Animal Research (ILAR) Guide. The SHIONOGI Institutional Animal Care and Use Committee (IACUC) and veterinary care team have a crucial role in advancing ethical and humane care and use of animals involved in research at SHIONOGI by reviewing all animal use protocols and conducting post-approval monitoring and inspections on implementation of animal experiments to ensure animal wellbeing and compliance with protocol and rule for animal experiment, as well as providing education and training for all personnel involved in the care and use of animals. SHIONOGI regularly acquires accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), an international third-party assessment organization that promotes the ethical and humane care and use of laboratory animals.