Research and Development

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Basic Policy

The Otsuka group carries out research and development guided by its corporate philosophy, “Otsuka-people creating new products for better health worldwide.” We conduct these activities with high ethical standards, including bioethics.

Research Involving Animals

The use of experimental animals to verify efficacy and safety in R&D is at times necessary. The Otsuka group complies with all related laws, ordinances, and guidelines, and adopts experimental methodologies that respect animal life and are appropriate from the perspective of animal welfare. As an in-house management system, we 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 principles, we conduct researcher education and internal inspections and evaluations of the implementation of experiments involving animals.

Research Involving Human-Derived Specimens

When conducting research using information or specimens collected from the human body, such as tissues or blood, the Otsuka group complies with all laws, ordinances, and guidelines and conducts scientifically and medically appropriate research that upholds ethical considerations. Each group company establishes committees that include outside members to ensure the appropriateness and credibility of research. The committees do so by examining research plans, the significance and goals of research, personal information management systems, research progress status, and research outcomes from the standpoints of ethical and scientific validity and of protection of personal information.

Research Involving Pathogenic Microorganisms (Pathogens) and Genetically Modified Organisms

In using pathogenic microorganisms (pathogens) or research samples that may contain these pathogens, the Otsuka group complies with all relevant laws and ordinances, including the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases (the “Infectious Diseases Control Act”). We have also established internal regulations regarding the safe management (handling and storage) of such pathogens and for environmental security, and work to prevent experiment-related accidents through employee education.

In experiments involving genetically modified organisms, we comply with all relevant laws and ordinances, including the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (the “Cartagena Act”). We also have an internal review committee, and take due care to avoid causing environmental damage through improper spread or leakage of genetically modified organisms.

Ethics in Clinical Trials

In developing new drugs and treatments, it is necessary to conduct clinical trials with the cooperation of patients and others in order to confirm the efficacy and safety of the drug or treatment. To ensure the human rights, safety and welfare of subjects, the Otsuka group has established a review committee to review clinical trials from ethical and scientific viewpoints, in addition to ensuring their compliance with ethical principles and standards, including ICH-GCP (Good Clinical Practice), an international standard for the implementation of clinical trials for pharmaceutical products. When conducting clinical trials, we follow internal regulations, standard operating procedures, and so on, and free and informed consent must be obtained in writing from each person cooperating in the clinical trial. We properly handle personal information obtained in the course of conducting clinical trials in accordance with our Basic Rules for Protection of Personal Information and other related rules.

Compliance in R&D by Otsuka Group Companies

Management of Public Research Funds

The Otsuka group has formulated rules for management and control of public research funds and for prevention of research misconduct, based on the Guidelines for Managing and Auditing Public Research Funds at Research Institutions and the Guidelines for Responding to Misconduct in Research established by the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry.

Management of Public Research Funds at Group Companies

Ethics in Development

In the development of pharmaceuticals, we confirm the safety and effectiveness of candidate compounds by conducting clinical trials with the cooperation of healthy individuals and patients. Recognizing the importance of ethical considerations regarding human rights and personal information, the Otsuka group implements clinical trials in compliance with ethical principles and standards, including ICH-GCP, an international standard for the implementation of clinical trials for pharmaceutical products.

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