Preface II
Introduction III
1 Scope 1
2 Normative References 1
3 Terms and Definitions 1
4 Monitoring and Reporting 4
4.1 Collection of Safety Information 4
4.2 Key Product Monitoring 4
4.3 Monitoring Sites and Personnel 5
4.4 Monitored Priority Populations 5
4.5 Reporting Adverse Reactions/Events 5
5 Signal Identification 5
6 Risk Assessment 5
6.1 Common Adverse Reactions 5
6.2 Risks of Combined Medication 6
6.3 Risks of Medication in Special Populations 6
6.4 Risks of Inappropriate Clinical Use 7
6.5 Other Risks 8
7 Risk Control 8
7.1 Measures for Handling Adverse Reactions 8
7.2 Risk Control for Combined Medication 8
7.3 Risk Control for Medication in Special Populations 9
7.4 Risk Control for Inappropriate Drug Use 9
7.5 Control of Other Risks 10
7.6 Development of a Monitoring Plan for Topical Medications 11
Appendix A (Informative) Classification of Toxicity of Chinese Herbal Medicine 12
Appendix B (Informative) Chinese Herbal Medicines Prohibited or Used with Caution in Pregnant Women 13
References 14
T/CACM 1563.6-2024 history
2024T/CACM 1563.6-2024 Pharmacovigilance guideline for clinical application of Chinese patent medicine for mucosal administration