As a pharmaceutical company dedicated to delivering innovative and groundbreaking new drugs to patients, it is our responsibility to provide high-quality, safe, and reliable pharmaceutical products. In the course of drug development, we place the highest priority on ensuring the human rights and safety of our clinical trial participants.

ONO manufactures all of its pharmaceutical products and investigational drugs under an appropriate quality assurance system. At our plants, we are working to establish systems that comply with global standards such as the GMP*¹ and PIC/S*² of various countries, as well as GMP, provide employee education and training, and develop risk management systems. In addition, as part of our audit framework, we have established quality audit departments that are independent from the GxP implementation departments, and we verify that appropriate manufacturing and quality control are being carried out through our own quality system and through other means such as regular audits of our contract manufacturers. In FY2025, there were no significant findings resulting from regulatory inspections, including the GMP inspections of ONO’s plants by the FDA (U.S. Food and Drug Administration).

In February 2026, we recalled our products from the Japanese, South Korean, and Taiwanese markets after determining that we could not completely rule out the possibility of foreign substance contamination during the manufacturing process for some of our injectable products. This product recall was a voluntary decision that was made to prioritize patient safety and to ensure that all the necessary precautions were taken. Please note that there is no risk of a health hazard resulting from this foreign substance contamination, and no reports have been received from the market. This response demonstrates ONO’s sense of responsibility and corporate stance toward safeguarding an environment in which customers can use ONO’s pharmaceutical products with peace of mind.

We place the safety of our patients as our top priority and are working to establish a globally consistent drug safety monitoring system. During the development phase, we strive to ensure the safety of clinical trial participants and to appropriately evaluate the safety profile of our pharmaceutical products by appropriately collecting and evaluating safety information obtained during clinical trials and responding promptly. Based on the belief that the safety profile of a pharmaceutical product is specific to each compound and that a unified evaluation and management system that transcends national and organizational boundaries is essential, we strive to strengthen our safety management system by developing and revising standard operating procedures and integrating safety information management systems in order to promote standardization at the global level.

• GMP (Good Manufacturing Practice): A standard for the manufacturing and quality control of pharmaceutical products.
• PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme): An informal cooperative arrangement among regulatory authorities. Its aim is to develop, implement, and maintain internationally harmonized GMP standards and the quality systems of regulatory authorities in the pharmaceutical sector.

We develop risk management plans for each pharmaceutical product and carry out safety management activities across the entire group. With regard to safety (side effects), we have several safety measures in place, such as evaluating collected information, revising package inserts as necessary, and providing notices on the proper use of pharmaceutical products. In implementing these safety measures, we evaluate them based on the opinions of external medical experts and promote proper use by disseminating information through information materials, academic conferences, and medical journals. Furthermore, particularly in the case of Opdivo, based on a wealth of post-marketing safety data, we have developed a digital tool that allows users to search for suspected immune-mediated side effects based on patients’ chief complaints and symptoms, and we are also undertaking new initiatives to facilitate the early detection and early treatment of side effects. In this way, we are pursuing initiatives to raise awareness about promoting proper use not only among prescribing specialists but also among allied health professionals.

For a pharmaceutical company, a quality culture serves as the foundation of its business activities. At ONO, we conduct training programs with the goal of cultivating a company-wide quality culture based on our corporate philosophy, “Dedicated to the Fight against Disease and Pain.”