TOKYO, February 1, 2017 - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it will make the following personnel changes, effective March 23, 2017, organizational and personnel changes, effective April 1, 2017.

【Details of Organizational Changes】

Effective April 1, 2017

• Project & Lifecycle Management Unit
  A rapid progress in science and technology such as life science and ICT will bring drastic changes to the society and the pharmaceutical industry. To take advantage of these changes as an opportunity for future growth, Science & Technology Intelligence Dept. will be newly established as an intelligence function which is equipped with high sensitivity, expertise and mobility.

• Quality & Regulatory Compliance Unit
  Quality & Regulatory Compliance Unit will be reorganized aiming to lead the Chugai Group toward maintenance and improvement of global Quality Assurance System through strengthening the main three functions, “Compliance,” “Quality” and “Regulatory” which are essential to assure drug quality.
  • Quality & Regulatory Compliance Dept., Quality Assurance Dept. and Regulatory Affairs Audit Dept. will be restructured into Business Strategy & Compliance Dept., Quality Assurance Dept. and Quality Initiative Dept.
  • The function of regulatory affairs management of the Regulatory Affairs Dept. in the Project & Lifecycle Management Unit, and the function of the post-marketing regulatory affairs of the Quality & Regulatory Compliance Unit will be partly transferred and integrated into the Regulatory Intelligence & Management Dept. which is newly established in the Quality & Regulatory Compliance Unit.
  • Functions of each departments
    • Business Strategy & Compliance Dept.: To Plan the strategies for the Unit and promote the GxP* compliance at global level
    • Quality Assurance Dept.: To assure the quality of investigational drugs and the products regarding manufacturing and marketing process
    • Quality Initiative Dept.: To address the challenges regarding global quality system, process improvements to ensure quality assurance
    • Regulatory Intelligence & Management Dept.: To coordinate the regulatory intelligence activities, manage post-marketing regulatory affairs and medical information quality at global level

  * GxP: Good x Practice which means the standard practices and regulations for the range of operations such as “development,” “manufacturing” and “marketing” of the pharmaceuticals.

  e.g.) GCP (Good Clinical Practice; the standard practice for conducting clinical studies)