State Drug Administration: The six-flavored yellow preparation instructions for a unified revision

Pharmaceutical Network February 18, according to the Website of the State Drug Administration, the State Drug Administration recently issued a notice that, according to the results of the drug adverse reaction assessment, in order to further protect the safety of public drug use, the State Drug Administration decided to six-flavored yellow preparations (including pills, capsules, tablets, adhesives, omelettes, granules) instructions "adverse reactions" (taboos) and "precautions" to make a unified revision.
According to the announcement, all licensed holders of all the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, revise the instructions in accordance with the revised requirements of the corresponding instructions and report them to the provincial drug regulatory departments for the record by May 2, 2021.
, the revised contents shall be revised together if they relate to drug labels, and the instructions and other contents of the labels shall be consistent with the original approval.
the original drug instructions for medicines produced on the date of filing.
drug market license holder shall replace the factory-issued drug instructions and labels within 9 months of filing.
announcement requires drug market license holders to conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures to do a good job in the publicity and training of drug use and safety issues, and guide physicians and patients to use drugs rationally.
clinicians should carefully read the revision of the above-mentioned drug instructions and conduct a full benefit/risk analysis in accordance with the newly revised instructions when selecting medications.
patients should carefully read the drug instructions before taking the drug, and if they use prescription drugs, they should strictly follow the medical advice.
the announcement stressed that the provincial drug supervision and administration departments should urge the drug market license holders of the above-mentioned drugs in the administrative area to do a good job in accordance with the requirements of the corresponding manual revision and labeling, manual replacement work, the violation of the law and strict investigation and punishment.