T/CACM 1381-2022 Active

Scope: This document provides the main technical specifications applicable to the evaluation and detection of allergic reactions to intravenous traditional Chinese medicine injections. This document is applicable to the non-clinical safety evaluation of intravenous traditional Chinese medicine injections during the R&D process, risk control during the production of marketed products, and post-marketing safety re-evaluation. At the same time, it can be used as a reference for enterprises, researchers, and testing personnel engaged in work related to traditional Chinese medicine injections in the evaluation, detection, and control of allergic risks. Note: This document cannot replace the current principles of drug allergy evaluation. The two documents complement each other. Main technical content: Foreword II Introduction III 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Trial operation key points 4.1 Overview of detection methods 4.2 Basic principles 4.3 Main reagents and equipment 4.4 Operating steps 5. Result observation and analysis 5.1 Result observation 5.2 Judgment criteria for test results 6. Precautions