T/CACM 1563.5-2024 Guidelines for Pharmacovigilance in the Clinical Application of External Traditional Chinese Medicine Products

Scope

Scope: This document provides guidance on the monitoring and reporting of adverse drug reactions/events, risk signal identification and assessment, and risk control measures for external use traditional Chinese medicines (TCMs) during their clinical application. This document is applicable to pharmacovigilance professionals, including drug marketing authorization holders (hereinafter referred to as "holders"), drug manufacturers, drug distributors, medical institutions, and scientific research institutes, who are involved in the pharmacovigilance work of external use TCMs during their clinical application. Main technical content: - Preface - Introduction - Chapter I: Scope - Chapter II: Normative references - Chapter III: Terminology and definitions - Chapter IV: Monitoring and reporting 44.1 Safety information collection 44.2 Key monitored drugs and drugs requiring special attention in clinical application 54.3 Monitoring sites and personnel 54.4 Key monitored populations 54.5 Reporting of adverse reactions/events 65. Signal identification 66. Risk assessment 66.1 Common adverse reactions/events of external use TCMs 66.2 Risks of combination therapy 66.3 Risks of medication in special populations 66.4 Risks of irrational drug use 66.5 Other risks 8. Risk control 87.1 Handling of common adverse reactions/events of external use TCMs 87.2 Risk control of combination therapy 87.3 Risk control of medication in special populations 87.4 Risk control of irrational drug use 87.5 Control of other risks 11. Appendix A (informative): External use TCMs included in the 2018 National Essential Drugs List 12. Appendix B (informative): External use TCMs included in the 2021 National Medical Insurance Drug List 13. Appendix C (informative): Classification of TCM toxicity 14. References

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