Preface II
Introduction III
1 Scope 1
2 Normative References 1
3 Terms and Definitions 1
4 Organization of Traditional Chinese Medicine (TCM) Drug Vigilance System in Medical Institutions 2
4.1 TCM Safety Committee in Medical Institutions 2
4.2 TCM Drug Vigilance Department in Medical Institutions 2
4.3 Ethics Committee 2
5 Related Systems for the TCM Drug Vigilance System in Medical Institutions 3
5.1 Training System 3
5.2 Monitoring and Reporting System 3
5.3 Risk Identification System for Safety 3
5.4 Risk Assessment System for Safety 3
5.5 Risk Control System 3
5.6 Quality Management System for the Operation of the System 4
5.7 Emergency Response Plan System 4
5.8 Ethics Review System 4
5.9 Document Management System 5
6 Platform Construction for TCM Drug Vigilance System in Medical Institutions 5
6.1 Supporting Conditions 5
6.2 Information System Construction 5
7 Activities of Traditional Chinese Medicine (TCM) Drug Vigilance in Medical Institutions 6
7.1 Drug Vigilance Activities During Clinical Trials 6
7.2 Post-Launch Drug Vigilance Activities 6
Appendix A (Informative) Report Form for Adverse Reactions/Incidents of Medicinal Products 11
References 12
T/CACM 1563.2-2024 history
2024T/CACM 1563.2-2024 Guidelines for the construction of Chinese materia medica pharmacovigilance system in medical institutions