Ethical considerations in animal experiments

SHIONOGI is consistently working on research and development of pharmaceutical products on the basis of its company policy of “SHIONOGI strives constantly to supply the best possible medicine to protect the health and well-being of the patients we serve.” Predicting the safety and efficacy of pharmaceutical products in humans is an extremely difficult challenge even with current science and technology, and we consider this a research field in which the need for animal experiments is high.

SHIONOGI has established its company regulations based on the “Basic Guidelines for the Conduct of Animal Experiments, etc. in the Implementing Agencies under the Jurisdiction of the Ministry of Health, Labour and Welfare,” and practices the internationally recognized principles of the 3Rs (replacement, reduction and refinement), which form the basic philosophy of animal experiments. We make every effort to ensure appropriate care and scientific use of animals with respect and a sense of responsibility toward animals, taking into account their physiology, ecology, and natural behaviors.

The SHIONOGI Institutional Animal Care and Use Committee (IACUC) reviews all animal study protocols ethically and scientifically and confirms the results of approved studies, thereby ensuring the proper implementation of animal experiments based on the principles of the 3Rs. The committee also provides continuous education and training to all personnel engaged in animal experiments to enhance their qualifications, sense of responsibility, and awareness of animal well-being.

In addition, we conduct self-inspections and evaluations regarding the care of laboratory animals and the conduct of animal experiments to ensure compliance with relevant laws, guidelines, and internal regulations. Furthermore, SHIONOGI continuously obtains accreditation from AAALAC International, an international third-party accreditation body for the ethical and humane care and use of laboratory animals.