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Compliance with Appropriate Implementation of Animal Experiments in Research and Development Activities at Otsuka Group Companies

Under the corporate philosophy of "Otsuka-people creating new products for better health worldwide", the Otsuka group of companies is actively engaged in research and development for products related to nutraceuticals that support daily health and innovative pharmaceuticals that aim to cure diseases. Use of laboratory animals in some areas of drug development is still necessary in order to validate the efficacy and safety of potential drug candidates prior to use in humans. For testing of Otsuka's non-drug product candidates, laboratory animals are used occasionally, and only when necessary. When implementing testing involving animals, Otsuka strives to uphold scientifically valid methodologies and ethical considerations from the viewpoints of animal protection and welfare, including the lives of the animals; preservation of the environment; and the safety of experimenters.

Otsuka adheres to the “Act on Welfare and Management of Animals”; the “Fundamental Guidelines for Proper Conduct of Animal Experiment and Related Activities in Implementing Institutions under the jurisdiction of the Ministry of Health, Labour and Welfare in Japan”; the “Guidelines for Proper Conduct of Animal Experiments” and related laws, regulations and guidelines.

In addition, as an in-house management system, we have established compliance programs for each Otsuka group company engaged in animal experiments, have developed and implemented rules on experiments that involve animals, have established an Animal Experiment Committee, and properly carry out animal experiments and breeding. The Animal Experiment Committee evaluates whether each proposed animal experiment plan is appropriate based on the 3Rs principles. These are Replacement/avoidance or replacement of animal use, Reduction/minimization in the number of animals used, and Refinement/minimization of animal suffering. Based on these, we conduct researcher education and internal inspections and evaluations of the implementation of experiments involving animals.