Center for Drug Evaluation – An Introduction
Organization

 Organization
The CDE recruits highly qualified professionals to achieve its vision and to fulfill its regulatory role. Most team members in the CDE have a strong background in medicine, pharmacy, chemistry, biology, statistics, biomedical engineering, law, pharmacoeconomics or other life science-related fields. At present, there are more than 220 full-time employees working at the CDE. The organization includes Office of Executive Director, Division of New Drugs, Division of Pharmaceutical Science, Division of Medical Devices, Division of Regulatory Affairs and Compliance, Division of Health Technology Assessment, Center of Consultation, and Department of General Affairs.

 Major Tasks
  • Technical Dossier Review on Drugs

    • Review Clinical Trial Protocol of Investigational New Drug (IND)
    • Review New Drug Application (NDA), and related license renewal and variations
    • Review Abbreviated New Drug Application (ANDA) for generic drugs, and related license renewal and variations
    • Review Bridging Study Evaluation (BSE) application
    • Review API / Drug Master File (DMF)
    • Review Dissolution / BA / BE Reports
    • Review OTC Application
  • Technical Dossier Review on Medical Devices

    • Review Clinical Trial Protocol of Medical Devices (IDE)
    • Review Clinical Study Report of Medical Devices
    • Review Pre-Market Approvals of Medical Devices (PMA), related license renewal and variations
    • Review special import application of medical devices
  • Health Technology Assessment (HTA)

    • Establish Standard Operating Procedures for evaluating Health Technology Assessment
    • Conduct Health Technology Assessment on cases designated by the competent authority
  • Advisory Services

    • Advices on general regulatory requirements
    • Advices on projects in the review processes
    • Advices on research projects of medical products (Index Cases Consultation Services)

 Management of Conflict of Interest
The CDE has put forth the “CDE’s Principles Regarding the Avoidance of Conflict of Interest” as a doctrine for all employees to follow in order to avoid direct or indirect conflict of interest which may involve any asset or non-asset benefits in connection with employees’ duties. Any misconduct shall be handled in accordance with the CDE Human Resource policies. Assets acquired through this violation shall be seized by the Center. Employees are responsible for all compensation and damage arising from the misconduct.