T/CACM 1563.4-2024 Active

Scope: This document provides guidance on monitoring, signal identification, risk assessment, and risk control in the clinical application of traditional Chinese medicine (TCM) injections. This document is applicable to drug marketing authorization holders (hereinafter referred to as "holders"), pharmaceutical manufacturers, distributors, medical institutions, scientific research institutes, universities, industry associations, etc. in conducting pharmacovigilance work for TCM injections. Main technical content: - Preface II - Introduction III - 1 Scope - 2 Normative reference documents - 3 Terms and definitions - 4 Monitoring and reporting - 4.1 Safety information collection - 4.2 Monitoring of key varieties - 4.3 Monitoring sites and personnel - 4.4 Key populations to be monitored - 5 Reporting - 6 Signal identification - 7 Risk assessment - 7.1 Common adverse reactions of TCM injections - 7.2 Risks of combination therapy - 7.3 Risks of medication in special populations - 7.4 Risks of irrational medication - 7.5 Other risks - 7.6 Development of pharmacovigilance plans - 10 Appendix A (informative) - List of marketed TCM injections and their distribution - 11 References - 15