The National Medical Products Administration (NMPA) announced the application of the ICH E6 (R3): Guideline for Good Clinical Practice, aligning China’s clinical trial quality management with international standards and reinforcing risk-based oversight for clinical trials.

Key Highlights:

  • Applicable Scope:
    • All drug clinical trials initiated after March 31, 2026 must comply with E6 (R3) requirements in China.
  • Risk-Based Quality Framework:
    • Encourages proactive risk identification and control across trial stages, enhancing subject protection and data reliability.
  • Global Harmonization:
    • Facilitates acceptance of internationally conducted clinical trial data and supports global synchronized drug development.
  • Guidance Accessibility:
    • The detailed E6 (R3) technical guidance will be made available on the NMPA Drug Evaluation Center’s website, and the Center will provide technical support during implementation.
  • Regulatory Support:
    • NMPA’s Drug Evaluation Center will oversee guidance implementation and offer technical assistance to sponsors.

Consult Now

Source
https://www.ccfdie.org/cn/yjxx/yphzp/webinfo/2026/01/1759934908759597.htm
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NMPA
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Regulatory Affairs