GB/T 47336-2026

Upcoming

Specification for quality control in traditional Chinese medicine clinical trials

中医药临床研究质量控制规范

Standard Type
GBT
ICS
03.100.40
CCS
C05
Status
Upcoming
Issue Date
2026-03-31
Implementation
2026-07-01
Centralized Committee
国家中医药局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the requirements for quality control in clinical trials of traditional Chinese medicine, covering trial design, implementation, data management, and ethical oversight. It is applied by research institutions, pharmaceutical companies, and clinical trial sites conducting TCM studies in China to ensure compliance with regulatory and scientific standards. The standard is particularly relevant for evaluating the safety and efficacy of TCM products, including herbal medicines and acupuncture, in human trials.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.