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.

Conditions that foster an awareness of quality

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 clearly indicate the vision and objectives for quality, understanding that quality takes precedence over cost and speed. 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, but at the same time, treatments have grown more sophisticated and complex, and there is a need to offer the right patients the appropriate therapies at the appropriate time. To achieve these goals, it is important that both healthcare providers and patients themselves actively participate in 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, e-mail and other diverse channels. Additionally, we are working to enhance the FAQ section of our website for healthcare providers and have also begun responding to inquiries using MI Chat (a chatbot), allowing us to receive inquiries through diverse channels. Taking advantage of the benefits of being a member of the Roche Group, it provides information that is both highly specialized and globally consistent.

Medical Information Dept. received approximately 46,000 inquiries in 2019, about 10,000 fewer than in the previous year, in part due to the transfer of long-term listed products and the expansion of inquiry channels. About 77% of inquiries came from pharmacists in hospitals or community pharmacies, about the same ratio as in the previous year. By drug category, anti-influenza agents accounted for about 21 percent of all inquiries. The center also received many inquiries concerning anticancer agents, osteoporosis treatments, humanized anti-human IL-6 receptor monoclonal antibody for treatment, and long-acting erythropoietin-stimulating agents.

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: 46,056 in 2019

Inquiries by Treatment Area (2019)

Graph showing changes in Inquiries by Treatment Area (2019): Oncology 28.0%, Bone/Joint/Rheumatism 32.0%, Renal/Cardiovascular/Infection diseases 12.0%, Anti-influenza agents 21.0%, Others 7.0%
  • * Percentages for key treatment areas excluding anti-influenza agents.
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Sustainable Patient-Centric Healthcare

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