T/CACM 1563.1-2024 Chinese patent medicine safety alert guideline

Scope

Scope: This document clarifies the four key steps of pharmacovigilance for traditional Chinese medicines (TCMs): monitoring, identification, evaluation, and control, as well as the main content of pharmacovigilance activities for TCMs. This document applies to pharmaceutical marketing authorization holders (hereinafter referred to as "holders"), pharmaceutical manufacturers, pharmaceutical distributors, medical institutions, scientific research institutes, universities, industry associations, etc. in conducting pharmacovigilance work for TCMs. Main technical content: - Preface III - Introduction IV - 1 Scope - 2 Normative reference documents - 3 Terms and definitions - 4 Purpose - 5 Monitoring and reporting - 5.1 Collection methods - 5.2 Monitoring forms - 5.3 Reporting - 6 Signal detection and identification - 6.1 Signal detection - 6.2 Detection methods - 6.3 Detection frequency - 6.4 Priority detection signals - 6.5 Signal priority judgment - 6.6 Signal evaluation - 6.7 Judging the full-chain association relationship - 6.8 Unexpected adverse drug reactions - 6.9 Clustered adverse events - 7 Risk assessment - 7.1 Principles - 7.2 Quality risk control of TCM raw materials and slices - 7.3 Quality risk control of pharmaceutical production - 7.4 Quality risk control of pharmaceutical storage and transportation - 7.5 Risk control during clinical trials of TCMs - 7.6 Risk control after TCMs are put on the market - 8 Pharmacovigilance activities for TCMs - 8.1 Safety literature evaluation - 8.2 Risk signal mining in spontaneous reporting systems - 8.3 Centralized monitoring in hospitals - 8.4 Additional monitoring - 8.5 Real-world studies - 8.6 Interventional studies - 8.7 Prescription sequence analysis and prescription sequence symmetry analysis - 8.8 Identification of safety public opinion risk signals - 9.1 Periodic Safety Update Reports (PSURs) - 10 Periodic Benefit-Risk Reports (PBPERs) - Appendix A (informative): Judgment of serious adverse drug reactions - Appe

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