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. Mitsubishi Tanabe Pharma 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, reduced burden on research subjects, and the protection of personal information.
The Mitsubishi Chemical Group (the MCG Group) has established the MCG Human Tissue Research Ethics Review Committee as an 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 Mitsubishi Tanabe Pharma clinical trials 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 also upholds the laws and regulations of the country in which the studies are conducted, as well as its own standards and clinical trial protocols. All volunteer trial subjects give their informed consent to do so. The Company’s highest priority is to ensure the safety of its trial subjects, protect their human rights, and safeguard and improve their personal welfare.
Mitsubishi Tanabe Pharma Clinical Trial Protocol Review Committee includes members from outside the Company and medical experts who are well-versed in clinical trial ethics. Before a trial is allowed to begin, the committee investigates the proposed study to confirm its ethical and its scientific validity.
In addition, the Company’s clinical trial management system is used to verify that studies are being properly administered, and we have established a system to ensure that the trial data is reliable.