T/CACM 1370.5-2021 Active

Scope: This document establishes the technical specifications for the revision of drug safety information for special populations in the product labels of listed traditional Chinese medicines. This document applies to the revision of drug safety information for special populations in the product labels of listed traditional Chinese medicines 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 Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines; — T/CACM 1370.2—2021: Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Adverse Reactions; — T/CACM 1370.3—2021: Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Contraindications; — T/CACM 1370.4—2021: Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Precautions; — T/CACM 1370.5—2021: Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Drug Use in Special Populations; — T/CACM 1370.6—2021: Technical Specifications for the Revision of Safety Information Items in the Product Labels of Listed Traditional Chinese Medicines—Warning Statements. Foreword II Introduction III 1 Scope 2 Normative Reference Documents 3 Terms and Definitions 4 Revision Entities 5 Revision Timeline 6 Revision Procedures 7 Revision Scope and Content 8 Information Collection 8.1 Search Time 8.2 Search Objects 8.3 Information Sourc