T/CACM 1370.4-2021 Active

Scope: This document establishes the technical specifications for the revision of the "Precautions" section in the product labeling of listed traditional Chinese medicines (TCMs). This document applies to the revision of the "Precautions" section in the product labeling 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 Labeling of Listed Traditional Chinese Medicines". The structure and names of the series are as follows: - T/CACM 1370.1—2021: General Technical Specifications for the Revision of Safety Information Items in the Product Labeling of Listed Traditional Chinese Medicines; - T/CACM 1370.2—2021: Technical Specifications for the Revision of Adverse Reactions in the Product Labeling of Listed Traditional Chinese Medicines; - T/CACM 1370.3—2021: Technical Specifications for the Revision of Contraindications in the Product Labeling of Listed Traditional Chinese Medicines; - T/CACM 1370.4—2021: Technical Specifications for the Revision of Precautions in the Product Labeling of Listed Traditional Chinese Medicines; - T/CACM 1370.5—2021: Technical Specifications for the Revision of Drug Use in Special Populations in the Product Labeling of Listed Traditional Chinese Medicines; - T/CACM 1370.6—2021: Technical Specifications for the Revision of Warning Statements in the Product Labeling of Listed Traditional Chinese Medicines. Preface 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 Sources 8.4 Information Retrieval Methods 9 Information Screening 10 Information Translation Strategies 10.1 Evidence Level Sorting 10.2 Information Translation Me