T/CACM 1563.4-2024 - Pharmacovigilance guidelines for clinical application of Chinese medicine injections

Scope: Preface II Introduction III 1 Scope 1 2 Normative References 1 3 Terms and Definitions 1 4 Monitoring and Reporting 2 4.1 Collection of Safety Information 2 4.2 Key Product Surveillance 3 4.3 Surveillance Sites and Personnel 3 4.4 Monitored Priority Populations 3 4.5 Reports 3 5 Signal Identification 3 6 Risk Assessment 4 6.1 Common Adverse Reactions of Traditional Chinese Medicine Injections 4 6.2 Risks of Combined Medication 4 6.3 Drug Risks for Special Populations 5 6.4 Risks of Irresponsible Clinical Medication Use 6 6.5 Other Risks 6 7 Risk Control 7 7.1 Risk Control for Adverse Reactions of Traditional Chinese Medicine Injections 7 7.2 Risk Control for Combined Medication 8 7.3 Risk Control for Drug Use in Special Populations 8 7.4 Risk Control for Irresponsible Medication Use 8 7.5 Other Risk Control Measures 9 7.6 Development of a Pharmaceutical Vigilance Plan 10 Appendix A (Informative) Listing and Distribution of Marketed Traditional Chinese Medicine Injections 11 References 15

T/CACM 1563.4-2024 history

2024 T/CACM 1563.4-2024 Pharmacovigilance guidelines for clinical application of Chinese medicine injections