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GUIDANCE Final

E6(R3) GCP Guideline Implementation Recommendations

CDE, August 2025 National Medical Products Administration
ABSTRACT — EDITORS' SUMMARY

NMPA implementation guidance for the 2020 GCP regulation. Clarifies sponsor and investigator obligations in practical inspection scenarios.

TRANSLATION — NOT AN OFFICIAL DOCUMENT

Translation provided by Apprvl via DeepL for reference. Authoritative text is the Chinese-language original.

View Chinese original on NMPA ↗
EXTERNAL LINK
EXTERNAL LINK www.cde.org.cn
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METADATA
TypeGUIDANCE
Year2025
VersionFinal
StatusCurrent
FormatPDF
Pages32
Size820 KB
Last reviewedFEB 2021
SOURCE
PDF · CANONICAL LINK https://www.cde.org.cn/ichWeb/attachment/downloadAttachment/61f7e64ee889b21286c6904ce0381718 ↗
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