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

1 Scope

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.

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.)

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