T/CACM 1563.3-2024 Active

Main Technical Content: Foreword II. Introduction III. Scope IV. Normative Reference Documents V. Terms and Definitions VI. Monitoring and Reporting 24.1. Safety Information Collection 24.2. Monitoring of Key Drugs 24.3. Monitoring Sites and Personnel 34.4. Key Monitored Populations 34.5. Reporting 35. Signal Identification 36. Risk Assessment 36.1. Adverse Reactions to Oral Traditional Chinese Medicines 36.2. Risks of Combined Drug Use 36.3. Risks of Medication in Special Populations 36.4. Risks of Clinically Unreasonable Use 56.5. Other Risks 67. Risk Control 67.1. Measures for Handling Adverse Reactions 67.2. Risk Control of Combined Drug Use 67.3. Risk Control of Medication in Special Populations 77.4. Risk Control of Unreasonable Drug Use 87.5. Other Risk Controls 87.6. Development of Pharmacovigilance Plans 9 Appendix A (Informational) - Guidelines/Expert Consensus on the Treatment of Diseases with Traditional Chinese Medicines 10 Appendix B (Informational) - Expert Consensus/Opinions/Recommendations on the Treatment of Diseases with Oral Traditional Chinese Medicines 12 Appendix C (Normative) - Chinese Search Databases and Search Strategies 14 References 15