Announcement of the State Drug Administration on Revising the Instructions for Dahuoluo Preparations (No. 1 of 2021)

According to the evaluation results of adverse drug reactions, in order to further ensure the safety of public medication, the National Medical Products Administration has decided to review the instructions of Dahuoluo preparations (including pills (Dami Pills, Xiao Mi Pills) and capsules) [Adverse Reactions], [Contraindications] and [Notes] Unified revision
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1.
All the marketing authorization holders of the above-mentioned drugs shall revise the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and the corresponding instructions for revision requirements (see appendix), and report to the provincial drug supervision and administration department for record before April 4, 2021
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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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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 guide physicians and patients in the rational use of drugs
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3.
Clinicians 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 supervise and urge the drug marketing license holders of the above-mentioned drugs in the administrative area to do the corresponding manual revision and label and manual replacement work as required, and severely investigate and punish violations of laws and regulations in accordance with the law
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Hereby announce
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Attachment: Requirements for the revision of the instructions of Dahuoluo preparations

State Food and Drug Administration

January 5, 2021

Annex to Announcement No.