Announcement of the State Food and Drug Administration on Revising the Insert Sheets of 4 Kinds of Drugs including Cold and Clearing Heat Preparations (No. 88 of 2021)

According to the evaluation results of adverse drug reactions, in order to further ensure the safety of the public use of drugs, the National Medical Products Administration has decided to make unified revisions to the four instructions of the cold and heat-clearing preparations [Adverse Reactions], [Contraindications] and [Precautions]
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The relevant matters are hereby announced as follows: 1.
The marketing authorization holders of the above-mentioned drugs shall submit to the provincial drug supervision before September 28, 2021, in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, in accordance with the requirements for the revision of the insert sheet (see appendix) Recorded by the management department
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If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content
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Drugs produced on the date of filing shall not continue to use the original drug instructions
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The holder of the drug marketing authorization shall replace the instructions and labels of the drugs that have been shipped out of the factory within 9 months after filing
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2.
The drug marketing license holder shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to conduct publicity and training on drug use and safety issues, and instruct physicians, pharmacists or patients to use drugs rationally
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3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug inserts, and when choosing medications, they should conduct a sufficient benefit/risk analysis based on the newly revised inserts
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4.
The patient should read the drug insert carefully before taking the medicine.
If using prescription drugs, they should strictly follow the doctor's advice
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5.
The provincial drug supervision and administration department shall promptly urge the drug marketing license holders of the above-mentioned drugs in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and severely investigate and deal with violations of laws and regulations in accordance with the law
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Special announcement
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Attachment: 1.
Requirements for revision of instructions for Ganmaoqingre preparations 2.
Requirements for revisions of instructions for Rupi Sanjie preparations 3.
Requirements for revisions of instructions for Xiaoerresuqing oral preparations (prescription drugs) 4.
Requirements for revisions to instructions for Xiaoerresuqing oral preparations (over-the-counter drugs) 5.
Pharyngitis tablets (capsules) instruction revision requirements National Medical Products Administration June 29, 2021, National Medical Products Administration Announcement No.
88 of 2021 Annex 1.
docx National Medical Products Administration Announcement No.
88 of 2021 Annex 2.
doc National Medicines Announcement No.
88 of 2021 Annex 3.
doc of the National Medical Products Administration Announcement No.
88 of 2021 Annex 4.
doc Announcement No.
88 of the State Drug Administration of 2021 Annex 5.
doc