T/CACM 1563.2-2024 Guidelines for Establishing a Pharmacovigilance System for Chinese Medicines in Medical Institutions

Scope

Scope: This document establishes the general principles for the construction of a pharmacovigilance system for traditional Chinese medicine (TCM) in medical institutions, and clarifies the organizational structure of the system, platform construction, and TCM pharmacovigilance activities. This document is applicable to medical institutions and medical-related units, and is used to guide the construction of a TCM pharmacovigilance system. Main technical content: - Preface - Introduction - Chapter I: Scope - Chapter II: Normative reference documents - Chapter III: Terms and definitions - Chapter IV: Organizational structure of the TCM pharmacovigilance system in medical institutions - 4.1 TCM Safety Committee in medical institutions - 4.2 TCM Pharmacovigilance Department in medical institutions - 4.3 Ethics Committee - 5 Related systems of the TCM pharmacovigilance system in medical institutions - 5.1 Training system - 5.2 Monitoring and reporting system - 5.3 Safety risk identification system - 5.4 Safety risk assessment system - 5.5 Risk control system - 5.6 Quality management system for system operation - 5.7 Emergency response plan system - 5.8 Ethics review system - 5.9 Document management system - 6 Construction of the TCM pharmacovigilance system platform in medical institutions - 6.1 Supporting conditions - 6.2 Construction of informatization systems - 7 TCM pharmacovigilance activities in medical institutions - 7.1 Pharmacovigilance activities during clinical trials - 7.2 Pharmacovigilance activities after market authorization - Appendix A (informative): Adverse Drug Reaction/Event Report Form - 12 References

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