T/CACM 1563.6-2024
Pharmacovigilance guideline for clinical application of Chinese patent medicine for mucosal administration (English Version)

Std & Spec
Standard No.
T/CACM 1563.6-2024
Language
Chinese, Available in English version
Release Date
2024
Published By
Group Standards of the People's Republic of China
Lastest
T/CACM 1563.6-2024
Scope
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 Product Monitoring 4 4.3 Monitoring Sites and Personnel 5 4.4 Monitored Priority Populations 5 4.5 Reporting Adverse Reactions/Events 5 5 Signal Identification 5 6 Risk Assessment 5 6.1 Common Adverse Reactions 5 6.2 Risks of Combined Medication 6 6.3 Risks of Medication in Special Populations 6 6.4 Risks of Inappropriate Clinical Use 7 6.5 Other Risks 8 7 Risk Control 8 7.1 Measures for Handling Adverse Reactions 8 7.2 Risk Control for Combined Medication 8 7.3 Risk Control for Medication in Special Populations 9 7.4 Risk Control for Inappropriate Drug Use 9 7.5 Control of Other Risks 10 7.6 Development of a Monitoring Plan for Topical Medications 11 Appendix A (Informative) Classification of Toxicity of Chinese Herbal Medicine 12 Appendix B (Informative) Chinese Herbal Medicines Prohibited or Used with Caution in Pregnant Women 13 References 14

T/CACM 1563.6-2024 history

  • 2024 T/CACM 1563.6-2024 Pharmacovigilance guideline for clinical application of Chinese patent medicine for mucosal administration



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