In pharmaceutical research and development, animal experiments may be necessary and are the only means of confirming efficacy and safety as pharmaceuticals. However, animal experiments involve sacrificing the lives and bodies of animals, and thus it is essential to take ethics into consideration. The Company has formulated “Guidelines for Proper Conduct of Animal Experiments” and complies with relevant laws, regulations, and guidelines, etc., giving due consideration to animal welfare with reference to all animal experiments. Our policies and the status of our initiatives is included in “Information Disclosure on Animal Experiments.”
All employees will remind themselves that drug discovery is founded on a respect for all life, and continue to contribute to the welfare of animals and people.
Discovery research using samples provided by patients, such as human tissue and cells, as well as information, such as treatment information, is increasingly important in the discovery of more effective, safe drugs. In implementing this type of research, it is essential to pay careful attention to ethical issues, such as the receipt of appropriate informed consent based on the patient’s free will, reduced burden on research subjects, and the protection of personal information.
The Company has established a Human Tissue Research Ethics Review Committee in conformance with the Ethical Guidelines for Life Sciences and Medical and Health Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology (MEXT); Ministry of Health, Labour and Welfare (MHLW); Ministry of Economy, Trade and Industry (METI)). This committee carefully reviews the ethical appropriateness and scientific rationality of research protocols. To promote objectivity and impartiality in these reviews, outside members are included to ensure that respect is given to a range of opinions and to facilitate appropriate reviews. To ensure full transparency, the Company posts the committee membership list, the rules governing the committee, and summaries of its proceedings on the research ethics committee reporting system established by MHLW.
All clinical trials by the Company are subject to strict standards. The Company follows the guidelines set by the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use/Good Clinical Practices (ICH-GCP), based on the Declaration of Helsinki. It evaluates trial protocols that prioritize protecting the safety and human rights of clinical trial participants, and improving their welfare, and conducts trials with the informed consent of subjects based on the patient’s free will, upholding the laws and regulations of the country in which the studies are conducted, as well as its own standards and clinical trial protocols, ensuring ethical and scientific validity.
In addition, we have established a system to ensure that trials are conducted and audited appropriately, and that clinical trial data is reliable.