Preface III
Introduction IV
1 Scope 1
2 Normative References 1
3 Terms and Definitions 2
4 Purpose 3
5 Monitoring and Reporting 3
5.1 Collection Routes 3
5.2 Monitoring Forms 3
5.3 Reporting 4
6 Signal Detection and Identification 4
6.1 Detection Signals 4
6.2 Detection Methods 4
6.3 Detection Frequency 4
6.4 Key Signals to Detect 5
6.5 Judgment of Signal Priorities 5
6.6 Evaluation of Signals 5
6.7 Full Chain Relationship Determination 5
6.8 Unexpected Adverse Drug Reactions 5
6.9 Aggregated Adverse Events 6
7 Risk Assessment 6
8 Risk Control 6
8.1 Principles 6
8.2 Quality Risk Control for Raw Materials and Decoctions of Traditional Chinese Medicine (TCM) 6
8.3 Quality Risk Control in Pharmaceutical Manufacturing 7
8.4 Quality Risk Control During Storage and Transportation of Pharmaceuticals 7
8.5 Quality Risk Control During Clinical Trials of Medicines 7
8.6 Quality Risk Control After Market Launch of Pharmaceuticals 7
9 Activities of TCM Pharmacovigilance 8
9.1 Safety Literature Evaluation 8
9.2 Mining Risk Signals from Spontaneous Reporting Systems 9
9.3 Hospital-based Monitoring 9
9.4 Additional Monitoring 9
9.5 Real-world Research 9
9.6 Intervening Studies 9
9.7 Prescription Sequence Analysis and Symmetry Analysis of Prescriptions 9
9.8 Identification of Safety Public Opinion Risk Signals 9
9.9 Periodic Safety Update Report (PSUR) 10
9.10 Periodic Benefit-Risk Report (PBPER) 10
Appendix A (Informative) Determination of Severe Adverse Drug Reactions 11
Appendix B (Informative) Incidence Rate of Adverse Reactions 12
References 13
T/CACM 1563.1-2024 history
2024T/CACM 1563.1-2024 Pharmacovigilance guidelines for Chinese patent medicines