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Description:

Governing Agencies and Guiding Principles

The China Food and. Drug Administration (CFDA) is responsible for clinical trial oversight, approval, and inspection for drugs. Ethics Committees (ECs) function similar to IRBs.

Useful Documents and Investigators’ Points to Consider

Points to Consider

  • The CFDA website does not provide application submission address information. The address is:
    CFDA Administrative Acceptance Service Center. A38, Beilishi Road,
    Xicheng District, Beijing 100810
  • All applications and supporting data submitted to the CFDA are required to be in Chinese.
  • Sponsors are responsible for providing insurance coverage for any unforeseen injury to research participants
  • The informed consent form should contain a statement describing the compensation a participant receives for participating in a trial.

Local Collaborating Institutions

 

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