Chapter 1　Purpose

The purpose of this quality policy is to establish a clear and comprehensive framework for maintaining and continuously improving the quality of the ONO Group’s pharmaceutical products and services. By setting out ONO Group’s commitment to quality, this policy aligns our business objectives with our responsibility to deliver safe and effective pharmaceutical products that enhance the well-being of our patients and the wider community.

Chapter 2　Definitions of Terminologies

Article 1　The terms used in this Global Policy are defined below.

1. "All Policies" mean Global Policies and other Policies (including rules, detailed rules, and other items equivalent to Individual Entity Policies.)
2. "Employee(s)" means directors, officers, regular employees, contract employees, and other employees of the ONO Group, including temporary staff and fixed-term employees.
3. “ONO Group” means Ono Pharmaceutical Co., Ltd. and each of Subsidiaries.
4. "OPHQ" means a global headquarters function of Ono Pharmaceutical Co., Ltd.
5. "Subsidiary(ies)" means an entity or entities in which Ono Pharmaceutical Co., Ltd. directly or indirectly holds a majority of voting rights (more than 50%) or otherwise exercises equivalent substantial control. Indirect ownership includes all entities in a continuous chain of control, such as subsidiaries and sub-subsidiaries.

Chapter 3　Scope

This Global Policy applies to each of ONO Group and Employees.

Chapter 4　Basic Principle

Article 1　Quality Vision Statement for Ono Group

Empowering Quality Excellence for a Safer and Healthier World

Within the DNA of ONO Group is a steadfast commitment to assuring the safety, efficacy, and reliability of every ONO Group’s product. By thus, ensuring the safety and well-being of all patients globally. We envision a future where ONO Group is continuously perceived as the cornerstone of compliance, recognized for its unwavering dedication to the delivery of quality products worldwide.

1. Patient-Centric Excellence

   Patients’ well-being and rights are our highest priority. We are also devoted to safeguarding data integrity and ONO Group’s products and reputation.

2. Quality

   Through our commitment to quality, we strive to improve the lives of patients by continuously providing patients and stakeholders with safe, effective and reliable products and services that meet regulatory requirements.

3. Integrity

   We are dedicated to upholding the highest levels of integrity and ethical conduct. We are committed to maintaining transparency, traceability, and accountability in all our processes, fostering trust and partnership with our stakeholders.

4. Continuous Improvement

   We are adopting emerging technologies and pioneering novel approaches to continuous improvement. By evaluating and embracing the latest advancements, we ensure our products not only meet current standards but aim to set new benchmarks for the future.

5. Collaborative Innovation

   We embrace an organizational culture of sharing knowledge, driving innovation, and adopting a ‘right first time’ risk-based approach – Quality by Design.

Supplementary Provisions

This Global Policy was approved by the Corporate Strategy & Planning Committee on January 19th 2024 and shall take effect on Apr 01, 2024.

Revision on April 1st, 2026