T/CACM 1563.6-2024 Active

Scope: This document provides guidance on the monitoring, identification, evaluation, and control of traditional Chinese medicines administered via mucosal routes during their clinical application. This document is applicable to drug marketing authorization holders (hereinafter referred to as "holders"), pharmaceutical manufacturers, trading enterprises, medical institutions, scientific research institutes, universities, industry associations, etc. in conducting pharmacovigilance work for traditional Chinese medicines administered via mucosal routes. Main technical content: - Preface II - Introduction III 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Monitoring and reporting 4.1 Safety information collection 4.2 Monitoring of key products 4.3 Monitoring sites and personnel 5. Monitoring of key populations 5.1 Reporting of adverse reactions/events 6. Signal identification 7. Risk assessment 7.1 Common adverse reactions 7.2 Risks of combination therapy 7.3 Risks of medication in special populations 7.4 Risks of irrational medication 8. Risk control 8.1 Measures for handling adverse reactions 8.2 Risk control of combination therapy 8.3 Risk control of medication in special populations 8.4 Risk control of irrational medication 9. Other risks 10. Development of pharmacovigilance plans for mucosal drug administration 11. Appendix A (informative) - Classification of toxicity of traditional Chinese medicines 12. Appendix B (informative) - Traditional Chinese medicines prohibited or cautioned against use during pregnancy 13. References 14.