Increasing Product Reliability

Chugai Group works hard to supply high-quality medicines and pharmaceuticals, and to ensure patients and healthcare providers use its products properly by offering timely and accurate delivery of quality information.

Policy for Regulatory Compliance and Quality Assurance

Chugai’s basic approach is set forth in the policy for regulatory compliance and quality assurance.
The policy for regulatory compliance and quality assurance places specific emphasis on the following four points (four qualities).

  1. Product quality
  2. Product information quality
  3. Business process quality
  4. Staff suitability

To provide high-quality products and information, Chugai believes it is important to ensure the quality of the business processes that generate them, and to secure suitable personnel to actually perform that work.

System for Ensuring Reliability in the Product Lifecycle

To provide patients and healthcare workers with products of superior efficacy and safety, Chugai engages in a continuous effort to ensure reliability across the product lifecycle, from R&D to application for approval, manufacturing and marketing, and approval withdrawal.

System for Ensuring Reliability in the Product Lifecycle

A diagram showing system for ensuring reliability in the product lifecycle

Activities to Foster a Culture of Quality

At Chugai, we believe in the importance of an organizational culture that pursues quality by initiating its own improvements in processes and rules. To continue to provide high-quality products, we are engaged in a number of activities designed to foster a culture of quality. We continue to build awareness through dialogue, encouraging our employees to think about what quality means to them and what matters most in improving quality, and ensuring that each of them is able to take independent action.

What Developing Quality Awareness Means

A diagram showing Chugai’s framework for Conditions that foster an awareness of quality: [Mindset and Attitude] Patients are always put first. Everyone always acts after considering “Why?” rather than following set procedures without question. Everyone takes an interest in quality and works autonomously to continually improve quality. [Communication] Necessary information is conveyed to the right individuals, irrespective of organization or seniority. People speak up without hesitation or fear. Previous mistakes and lessons learned are passed on. [Employee Ownership] All employees see quality as their personal responsibility. All employees work together to meet common quality objectives. [Leadership] Executives and management communicate the importance of quality through quality objectives and a vision. Executives and management take the initiative and set an example for others. Executives and management give credit and support for decisions and actions to improve quality.

Handling of Inquiries by the Medical Information Department

Advances in scientific technology in recent years have seen the development of many innovative drugs and treatment methods. There is a need to offer the appropriate therapies at the appropriate times to patients who need them. To achieve these goals, it is important that both healthcare providers and patients themselves actively participate in the treatment, and pharmaceutical companies are increasingly required to provide more detailed information in lay terms on product quality, effectiveness and safety to ensure that drugs are used appropriately.

Chugai’s Medical Information Dept. responds to inquiries from patients, their families and healthcare providers via telephone, our website, and other diverse channels using resources available to members of the Roche Group to provide information that is highly specialized and globally consistent. In 2022, the Medical Information Dept. received approximately 35,000 inquiries by phone and other means, about 8,000 less than in the previous year, mainly due to a decrease in inquiries concerning treatments for the novel coronavirus (COVID-19). About 70% of inquiries came from pharmacists. By drug category, there were many inquiries concerning, humanized anti-human IL-6 receptor monoclonal antibody preparations, osteoporosis treatments, and anticancer agents. The website for healthcare professionals responds to inquiries by posting frequently asked questions and using MI Chat (a chatbot), and the WebFAQ for patients has also been launched. In 2022, approximately 55,000 frequently asked questions were browsed and approximately 3,000 inquiries were made using MI Chat.

The staff at the center will continue working together to enhance customer satisfaction with a patient-oriented philosophy.

Number of Inquiries Received

Graph showing changes in the number of inquiries: 35,355 in 2022

Inquiries by Treatment Area

Graph showing changes in Inquiries by Treatment Area (2022): Bone/Joint/Rheumatism 43.0%, Oncology 30.0%, Renal/Transplantation Immunology/Neurology/Hemophilia/etc. 17.0%, Infectious diseases 6.0%, Others 4.0%
  • * Percentages for key treatment areas excluding anti-influenza agents.
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