As a company committed to contributing to the health and beauty of all people, we place great importance on high ethical standards and social responsibility in our research and development activities. Our group conducts research on a diverse range of products, from prescription drugs to over-the-counter (OTC) medications and cosmetics. In conducting research and development, we fulfill our ethical, legal, and social responsibilities, while maintaining an ethical stance based on respect for human rights, ensuring safety, and transparent information disclosure. We pursue scientific and ethical approaches that are in line with the times, and promote research activities that earn the trust of society.
Handling and ethical practices of human tissue-derived samples
At Rohto Pharmaceutical, we conduct research and development using human tissue as part of our efforts to explore the possibilities of new treatments, including Regenerative medicine. When conducting research using such human samples, we place the utmost importance on giving full consideration to the human rights and privacy of those who provide the samples. Based on the "Ethical Guidelines for Life Science and Medical Research Involving Human Subjects," we carefully review research projects using human samples with an ethics review committee composed of internal and external experts, and proceed only after thoroughly confirming the appropriateness and validity of the research. When we ask for cooperation in research, we request that medical institutions explain the content and purpose, and that we obtain the individual's understanding and consent before requesting the provision of samples. We also pay close attention to the handling of personal information and genetic information, and thoroughly manage them appropriately in accordance with the law. Furthermore, we require researchers involved in research to take ethics training, and we strive to ensure that they always work with the latest knowledge and awareness. Through these mechanisms, we aim to practice ethical and socially responsible research activities.
Initiatives on the Use of Animal and Animal Testing Alternatives in Research Activities
Animal testing is essential for the research and development of pharmaceuticals and medical devices to confirm their safety and effectiveness. Our group's research laboratories have established internal regulations based on the "Act on Welfare and Management of Animals," the "Standards for the Rearing, Keeping, and Alleviation of Pain of Laboratory Animals," and the "Basic Guidelines for the Implementation of Animal Experiments, etc., in Implementing Organizations under the Jurisdiction of the Ministry of Health, Labour and Welfare," etc., to ensure that animal experiments are conducted appropriately from a scientific and animal welfare perspective.
The Animal Experiment Ethics Committee reviews whether experimental plans adhere to the "3R principles": Refinement (reducing suffering), Replacement (using alternative methods), and Reduction (reducing the number of animals used). We also conduct self-assessments and regularly undergo certification by third-party organizations. Our company operates under a policy of not conducting animal testing in the development of cosmetics (including medicated cosmetics), and we are developing products using alternative methods to animal testing. *
This allows us to develop safer and more effective products while fulfilling our social responsibility.
*Excluding cases where there is a responsibility to explain safety to society or where required by government in some countries.
Handling of Biomaterials and Genetically Modified Organisms
At Rohto Pharmaceutical, we are actively engaged in the development of next-generation medical technologies, including Regenerative medicine and gene therapy. While these research projects may involve handling genetically modified organisms and biomaterials, we prioritize safety above all else, operating under strict rules based on laws and regulations. Experiments are conducted in accordance with national laws (such as the Cartagena Protocol *) and the "Regulations for the Safety Management of Recombinant DNA Experiments." Before commencing any experiment, a specialist committee verifies safety and compliance with laws and regulations. Employees involved in research acquire knowledge and awareness of safety through training upon joining the company and through regular training. We also employ managers with qualifications stipulated by laws and regulations to ensure thorough risk management. We will continue to conduct research that supports the future of medicine, while valuing safety and ethics, and remain a company trusted by society.
* Act on the Conservation of Biological Diversity through Regulations on the Use of Genetically Modified Organisms, etc.
Approach to Clinical Trials
At Rohto Pharmaceutical, we respect the dignity, rights, and safety of subjects when conducting clinical trials for pharmaceuticals and medical devices, and we thoroughly protect personal information. Furthermore, we make it a principle to fully explain the purpose, methods, risks, and benefits of the trial to subjects and obtain informed consent based on their free will. Trials are reviewed for ethical and scientific merit by an external, independent committee (Institutional Review Board/Ethics Review Board) and are conducted only after approval. During the trial, we also give consideration to the safety of subjects and conduct trials in compliance with pharmaceutical regulations, the Clinical Research Act, the GCP Ordinance, and the Declaration of Helsinki. We provide regular ethical education to researchers involved in clinical trials and keep them informed of the latest information and standards. Through these standards, we ensure the trust of society and promote research that emphasizes ethical conduct.
Education and training
We strive to ensure that our employees involved in research and development are always equipped with the latest knowledge and awareness through necessary ethics education and regular training.