T/CACM 1370.6-2021 Active

Scope: This document establishes the technical specifications for the revision of warning items in the product manuals of listed traditional Chinese medicines. This document applies to the revision of warning items in the product manuals 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 Manuals of Listed Traditional Chinese Medicines", the structure and names of which are as follows: — T/CACM 1370.1—2021: Technical Specifications for the Revision of Safety Information Items in the Product Manuals of Listed Traditional Chinese Medicines—General Provisions; — T/CACM 1370.2—2021: Technical Specifications for the Revision of Safety Information Items in the Product Manuals of Listed Traditional Chinese Medicines—Adverse Reactions; — T/CACM 1370.3—2021: Technical Specifications for the Revision of Safety Information Items in the Product Manuals of Listed Traditional Chinese Medicines—Contraindications; — T/CACM 1370.4—2021: Technical Specifications for the Revision of Safety Information Items in the Product Manuals of Listed Traditional Chinese Medicines—Precautions; — T/CACM 1370.5—2021: Technical Specifications for the Revision of Safety Information Items in the Product Manuals 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 Manuals of Listed Traditional Chinese Medicines—Warnings. Preface II Introduction III 1 Scope 2 Normative Reference Documents 3 Terms and Definitions 4 Revision Subjects 5 Revision Time 6 Revision Procedure 7 Revision Scope and Content 8 Information Collection 9 Information Screening 9.1 Screening of Warning Information in the Product Manual 9.2 Warning Content in Public Announcements 10 Information Transformation Strategies