Ensuring stable supply, safety and reliability as a pharmaceutical company

Kyowa Kirin Group Quality Policy

Established on February 17, 2009
Revised on November 1, 2023

1. Purpose
   The Kyowa Kirin Group will contribute to the health and well-being of people around the world by consistently providing world-class quality pharmaceutical products and services in compliance with our global quality, safety and compliance policies.
   This policy is to describe the basic principles for quality of the Kyowa Kirin Group.
2. Scope of Application
   This policy applies to all personnel including officers and employees of the Kyowa Kirin Group. The Kyowa Kirin Group will request all of our business partners and agents engaged in our products and services to act in accordance with the basic principles stated in this policy.
3. Definition of Terms
   • GxP means GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GQP (Good Quality Practice), GDP (Good Distribution Practice) and GVP (Good Vigilance Practice).
   • Quality management system is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
4. Basic Principles
   We will act in accordance with the following basic principles.
   • Compliance and Continuous Improvement -
     We conduct our business in compliance with all global laws, regulations, and guidelines related to GxP. To ensure compliance, we will continuously improve our quality management system.
   • Cooperation and Collaboration with Stakeholders -
     We maintain sound relationships with regulatory authorities, suppliers, and contractors around the world to ensure a continuous supply of high-quality pharmaceutical products.
   • Predictive and Preventive Quality Assurance -
     We strive to prevent problems before they occur by using information and digital technologies to proactively identify and address risks.
   • Fostering a Quality Culture -
     We foster a healthy Quality Culture in our organization, openly discussing issues, and collaborating with our teams to ensure that we always act with integrity from the patient's perspective.

Kyowa Kirin Group Transparency Policy for the Relationships between Corporate Activities, Healthcare Professionals, Healthcare Organizations and Patient Organizations

Established on May 26, 2017
Revised on March 14, 2019

We at the Kyowa Kirin Group who strive to contribute to the health and well-being of people around the world collaborate with medical personnel and institutions (hereafter referred to collectively as "the Medical Community") and patient organizations in pursuit of innovative drug discovery, promotion of proper use of medication and patient-participatory medical care.
We will ensure high ethical standards in our relationships with the Medical Community and patient organizations. To be accepted as a reliable corporate group in society, we will disclose the information on the transfer of values to the Medical Community and patient organizations (hereafter referred to as "Transparency") in line with the following principles.

1. We will act in the best interests of patients in our interactions with the Medical Community and patient organizations.
2. We will disclose information on the transfer of values to the Medical Community and patient organizations in countries where we operate, while complying with the related laws, guidelines and industry codes for Transparency.
3. We will establish and operate appropriate organizational structures and business processes to ensure timely and accurate disclosure in accordance with the above applicable laws, guidelines and industry codes.