##  [China: Adoption of ICH E6(R3) Good Clinical Practice](/index%2ephp/mandate/china-adoption-of-ich-e6r3-good-clinical-practice) 

January 7, 2026

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.



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Source

<https://www.ccfdie.org/cn/yjxx/yphzp/webinfo/2026/01/1759934908759597.htm>

 

 

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