T/CACM 1622-2024 Guidelines for analyzing post-marketing safety evaluation data of traditional Chinese medicine

Scope

Scope: This document provides basic requirements for data, data sources, and analysis methods for post-marketing safety evaluation of traditional Chinese medicines (TCMs). This document is applicable to drug regulatory authorities, marketing authorization holders, pharmaceutical manufacturing and trading enterprises, medical institutions, universities, and research institutes conducting post-marketing safety evaluations of TCMs. Main technical content: Foreword II. Introduction III. 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Basic requirements for data used in post-marketing safety evaluation of TCMs 4.1. Relevance 4.2. Authenticity 4.3. Comprehensiveness 4.4. Completeness 4.5. Traceability 4.6. Ethical considerations 5. Sources of data for post-marketing safety evaluation of TCMs 5.1. Information systems such as ADR/ADE monitoring 5.2. Clinical studies 5.3. Pharmacotoxicology studies 5.4. Journal literature 5.5. Gray literature 6. Analysis methods for post-marketing safety evaluation of TCMs 6.1. Descriptive statistical analysis 6.2. Odds ratio imbalance method 6.3. Bayesian method 6.4. Association rules 6.5. Decision trees 6.6. Regression analysis 6.7. Meta-analysis 6.8. Neural networks 6.9. Random forests 6.10. Support vector machines 7. References

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