T/CACM 1370.1-2021 Active

Scope: This document establishes the basic principles and technical specifications for the revision of safety information items in the product labels of listed traditional Chinese medicines (TCMs). This document applies to the revision of safety information items in the product labels by the holders of drug marketing authorizations. Main technical content: This document is one of the series of standards for the "Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines", the structure and names of which are as follows: - T/CACM 1370.1—2021: General Provisions for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines; - T/CACM 1370.2—2021: Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Adverse Reactions; - T/CACM 1370.3—2021: Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Contraindications; - T/CACM 1370.4—2021: Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Precautions; - T/CACM 1370.5—2021: Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Drug Use in Special Populations; - T/CACM 1370.6—2021: Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Warning Statements. Preface II Introduction III 1. Scope 2. Normative Reference Documents 3. Terms and Definitions 4. Basic Principles 34.1 Legality 34.2 Practicability 34.3 Continuity 34.4 Standardization 5. Functional Requirements 5.1 Basic Functions 5.2 Extended Functions 6. Technical Requirements 6.1 Revision Subjects 6.2 Revision Timing 6.3 Revision Procedures 6.4 Revision Methods 6.5 Revision Format and Style 7. Scope of Technical Specifications 8. Appendix A (Informative) Preparation Proce