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 Medicines for Special Monitoring and Clinical Attention 5
4.3 Monitoring Sites and Personnel 5
4.4 Key Monitored Populations 5
4.5 Adverse Reactions/Events Reporting 6
5 Signal Identification 6
6 Risk Assessment 6
6.1 Common Adverse Reactions/Events of Topical Chinese Patent Medicines 6
6.2 Risks of Combined Medication 7
6.3 Risks of Medication for Special Populations 7
6.4 Risks of Inappropriate Medication in Clinical Practice 7
6.5 Other Risks 8
7 Risk Control 8
7.1 Handling Common Adverse Reactions/Events of Topical Chinese Patent Medicines 8
7.2 Risk Control of Combined Medication 9
7.3 Risk Control for Medication for Special Populations 9
7.4 Risk Control for Inappropriate Medication 10
7.5 Control of Other Risks 11
7.6 Development of a Monitoring Plan for Topical Chinese Patent Medicines 12
Appendix A (Informative)：Topical Chinese Patent Medicines in the 2018 National Basic Drug Directory 13
Appendix B (Informative)：Topical Chinese Patent Medicines in the 2021 National Medical Insurance Directory 14
Appendix C (Informative)：Classification of Chinese Herbal Toxicity 16
References 17
T/CACM 1563.5-2024 history
2024T/CACM 1563.5-2024 Pharmacovigilance guideline for clinical application of Chinese patent medicine for external use