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GB/T 47336-2026Specification for quality control in traditional Chinese medicine clinical trials (English PDF)

中医药临床研究质量控制规范

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 31, 2026

Implementation date

July 1, 2026

Scope

GB/T 47336-2026 is the English-translated version of 中医药临床研究质量控制规范.

GB/T 47336-2026 is the Chinese standard "Specification for quality control in traditional Chinese medicine clinical trials". Its scope clause reads: This document specifies the general requirements, quality control personnel, quality control plan, and primary quality control for quality control in clinical research of traditional Chinese medicine.

This includes secondary quality control, tertiary quality control (when necessary), and record management. This document applies to clinical research projects in traditional Chinese medicine, clinical research on traditional Chinese medicine/medical devices for registration purposes, and the marketing of traditional Chinese medicine.

Quality control work in post-clinical studies, etc. Its clauses include terms and definitions.

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Document preview — GB/T 47336-2026

National Standard of the People's Republic of China

ICS: 03.100.40
Classification: C 05

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Preface
Introduction
1.Scope
2 Normative References
3.Terms and Definitions
4.General Requirements
5.Requirements for Quality Control Personnel
6.Quality Control Plan
7.Level 1 Quality Control
8.Secondary quality control
9.Three-level quality control (if necessary)
10.Records Management
Appendix A (Informative) Quality Control Contents for TCM Syndrome Diagnosis and Efficacy Evaluation
Appendix B (Normative) Quality Control Report Form
Appendix C (Informative) Example of a Quality Control Plan Representation
References

1 Scope

This document specifies the general requirements, quality control personnel, quality control plan, and primary quality control for quality control in clinical research of traditional Chinese medicine.

This includes secondary quality control, tertiary quality control (when necessary), and record management.

This document applies to clinical research projects in traditional Chinese medicine, clinical research on traditional Chinese medicine/medical devices for registration purposes, and the marketing of traditional Chinese medicine.

Quality control work in post-clinical studies, etc.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1

Traditional Chinese medicine, originating in China, is characterized by holism and dialectical reasoning. It encompasses the medicine of the Han Chinese and ethnic minorities.

A general term for traditional Chinese medicine.

[Source. GB/T 38324-2019, 3.1]

3.2 Clinical research; CR

Scientific studies conducted on humans or human samples to assess the safety and effectiveness of drugs or medical devices.

3.3 Clinical Trial of Drug (CTD)

Human trials (patients or healthy subjects) aim to discover or validate the clinical, pharmacological, and clinical efficacy of an investigational drug.

Other pharmacodynamic effects, adverse reactions, or the absorption, distribution, metabolism, and excretion of the investigational drug are used to determine the efficacy and safety of the drug.

Systematic test.

3.4

In qualified institutions, the safety and... (The sentence is incomplete and requires more context to be translated accurately.)

The process of confirming validity.

3.5 Quality control (QC)

In a clinical research quality assurance system, the techniques implemented to verify that all relevant activities in a clinical research study meet quality requirements are...

Activity.

3.6 Key data; CD

Data used to ensure the reliability of clinical research results and the safety of subjects.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

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