T/CACM 1370.3-2021 Active

Scope: This document establishes the technical specifications for the revision of the [Contraindications] section in the product manuals of listed traditional Chinese medicines. This document applies to the revision of the [Contraindications] section in the product manuals of listed traditional Chinese medicines by drug marketing authorization holders, and can also serve as a reference for the industry and drug regulatory authorities in guiding the revision of the [Contraindications] section in traditional Chinese medicine product manuals. Main technical content: This document is one of the series of standards for the Revision of Safety Information Items in Product Manuals of Listed Traditional Chinese Medicines, with the following structure and names of the series: — T/CACM 1370.1—2021: Technical Specifications for the Revision of Safety Information Items in Product Manuals of Listed Traditional Chinese Medicines—General Principles; — T/CACM 1370.2—2021: Technical Specifications for the Revision of Safety Information Items in Product Manuals of Listed Traditional Chinese Medicines—Adverse Reactions; — T/CACM 1370.3—2021: Technical Specifications for the Revision of Safety Information Items in Product Manuals of Listed Traditional Chinese Medicines—Contraindications; — T/CACM 1370.4—2021: Technical Specifications for the Revision of Safety Information Items in Product Manuals of Listed Traditional Chinese Medicines—Precautions; — T/CACM 1370.5—2021: Technical Specifications for the Revision of Safety Information Items in 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 Product Manuals of Listed Traditional Chinese Medicines—Warnings. This document is T/CACM 1370.3—2021: Technical Specifications for the Revision of Safety Information Items in Product Manuals of Listed Traditional Chinese Medicines—Contraindications. Pr