GB/T 47139-2026Laboratory animals - Technical specification for the identification and evaluation of experimental animal models (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the Ministry of Science and Technology of the People's Republic of China. This document is under the jurisdiction of the National Technical Committee on Standardization of Laboratory Animals (SAC/TC281). This document was drafted by: Ningbo University, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, and China Medical... Institute of Laboratory Animal Science, Chinese Academy of Agricultural Sciences; Institute of Atomic Energy Utilization, Chinese Academy of Agricultural Sciences; Henan University of Traditional Chinese Medicine; Hebei University of Science and Technology Hebei North University, Academy of Military Medical Sciences of the Chinese People's Liberation Army, and Xi'an Jiaotong University. The main drafters of this document are. Liu Xinmin, Qin Chuan, Jiang Ning, Chen Ying, Wang Qiong, Sun Xiuping, Yang Mengjie, Li Wei, Yang Zhiwei, Lu Cong, and Miao Mingsan. Zhang Danshen, Chang Qi, Zhu Xiaoxin, Li Yunfeng, Zhang Liming, Xu Shujun, Kong Qi, Wang Ning, Liu Enqi, Pan Ruile, Tian Shuo, Song Yagang, Peng Bo, Li Hongmei Zhang Yiwen, Sun Xinran, Chen Fang, Li Mengting. Technical Specifications for Identification and Evaluation of Laboratory Animal Models

1 Scope

GB/T 47139-2026 is the Chinese national standard covering validating an animal model - the evidence that the animal actually reproduces the human disease it stands for, in its mechanism, its course and its response to treatment, and the documentation that lets another laboratory reproduce it. Most of the failures in translational research come from models that were never validated in this way. First edition, under the Ministry of Science and Technology. It was issued on 28 January 2026 and has been in force since 1 August 2026, as a first edition. The document is under the responsibility of the Ministry of Science and Technology. This page is published from the official record of the 2026 edition; the clause text of a standard this recent is not yet in circulation, and the figures, limits and tables it contains are those of the document itself, delivered in full with the English translation.

This document establishes the principles for the identification and evaluation of experimental animal models, and specifies the main contents and procedural requirements for identification and evaluation. This document applies to basic research in medicine, life sciences, pharmacy, and traditional Chinese medicine, as well as pharmaceutical and health products (including drugs and health foods). A general guide for the identification and evaluation of experimental animal models needed for the safety and efficacy evaluation of products, cosmetics, and medical devices.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

GB 14923 Genetic quality control of laboratory animals

GB 14925 Laboratory Animal Environment and Facilities

GB 19489 General Requirements for Laboratory Biosafety

GB/T 34791 Requirements for Quality Control of Laboratory Animals

GB/T 35823 General Requirements for Laboratory Animals

GB/T 35892 Guidelines for Ethical Review of Laboratory Animal Welfare

GB/T 39650 Nomenclature Rules for Laboratory Animal Strains (Mice and Rats)

GB/T 43051 General Requirements for Biosafety in Laboratory Animals

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 The methods for preparing experimental animal models and the detection indicators are reviewed and identified to determine whether the experimental animal models have been successfully created.

3.2 The importance, innovativeness, clinical fit, reproducibility, stability, success rate, and generalizability of experimental animal models were comprehensively evaluated. Achieve a comprehensive rating.

4.Principles of Identification and Evaluation Laboratory animal model identification and evaluation institutions organize reviews in accordance with the principles of fairness, impartiality, openness, objectivity, and scientific rigor, including the selection of review experts. The process includes selection, document review, meeting organization, and expert voting. Expert selection follows the principle of avoiding conflict of interest or having the same legal entity as the expert. (This is in accordance with the application process.) Please classify and evaluate the categories.