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 Monitoring 2
4.3 Monitoring Sites and Personnel 3
4.4 Monitored Priority Populations 3
4.5 Reporting 3
5 Signal Identification 3
6 Risk Assessment 3
6.1 Adverse Reactions to Oral Traditional Chinese Medicine (TCM) Preparations 3
6.2 Risks of Combined Medication 4
6.3 Risks in Special Populations 4
6.4 Risks of Inappropriate Clinical Use 5
6.5 Other Risks 6
7 Risk Control 6
7.1 Measures for Handling Adverse Reactions 6
7.2 Risk Management of Combined Medication 6
7.3 Risk Management in Special Populations 7
7.4 Risk Management of Inappropriate Medication Use 8
7.5 Other Risk Management 8
7.6 Development of a Pharmaceutical Vigilance Plan 9
Appendix A (Informative) Guidelines/Expert Consensus on the Treatment of Diseases with TCM Preparations 10
Appendix B (Informative) Expert Consensus/Opinions/Advice on the Treatment of Diseases with Oral TCM Preparations 12
Appendix C (Normative) Chinese Search Databases and Search Strategies 14
References 15
T/CACM 1563.3-2024 history
2024T/CACM 1563.3-2024 Pharmacovigilance guidelines for clinical application of oral Chinese patent medicine