T/CACM 1370.2-2021 Active

Scope: This document establishes the technical specifications for the revision of the "Adverse Reactions" section in the product labels of listed traditional Chinese medicines (TCMs). This document applies to the revision of the "Adverse Reactions" section in the product labels of listed TCMs by drug marketing authorization holders. 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. Preface II Introduction III 1 Scope 2 Normative Reference Documents 3 Terms and Definitions 4 Revision Subject 5 Revision Timeline 6 Revision Procedure 7 Revision Scope and Content 8 Information Collection 8.1 Search Timeline 8.2 Search Objects 8.3 Information Sources 8.4 Information Search Methods 9 Information Scree