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According to the results of adverse drug reaction assessment, in order to further protect the safety of public medication, the State Medical Products Administration decided to uniformly revise
the [adverse reactions], [contraindications] and [precautions] items in the drug instructions of Pediatric Baotaikang Granules, Xinkeshu Preparation, Maple Lotus Gastroenteric Health Preparation, and Awakening Spleen and Raising Children Granules.
The relevant matters are hereby announced as follows:
the [adverse reactions], [contraindications] and [precautions] items in the drug instructions of Pediatric Baotaikang Granules, Xinkeshu Preparation, Maple Lotus Gastroenteric Health Preparation, and Awakening Spleen and Raising Children Granules.
The relevant matters are hereby announced as follows:
1.
The MAHs of the above-mentioned drugs shall amend the instructions in accordance with the requirements of the corresponding annexes in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, and report to the provincial drug regulatory department for the record
before March 27, 2023.
The MAHs of the above-mentioned drugs shall amend the instructions in accordance with the requirements of the corresponding annexes in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, and report to the provincial drug regulatory department for the record
before March 27, 2023.
Where the content of the revision involves the labeling of drugs, it shall be revised together; Other contents of the instruction manual and label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug insert.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug insert.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug MAHs shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in publicizing and training on drug use and safety issues, and guide physicians, pharmacists or patients in the rational use of drugs
.
Drug MAHs shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in publicizing and training on drug use and safety issues, and guide physicians, pharmacists or patients in the rational use of drugs
.
3.
Clinicians and pharmacists should carefully read the revised contents of the above drug inserts, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
Clinicians and pharmacists should carefully read the revised contents of the above drug inserts, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's advice
.
Patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's advice
.
5.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job of revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with
violations of laws and regulations in accordance with law.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job of revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with
violations of laws and regulations in accordance with law.
This is hereby announced
.
.
Attachments: 1.
Pediatric Baotaikang granule drug manual revision requirements
Pediatric Baotaikang granule drug manual revision requirements
2.
Revision requirements for drug inserts of Xinkeshu preparations
Revision requirements for drug inserts of Xinkeshu preparations
3.
Revision requirements for the drug label of maple gastroenteric preparation
Revision requirements for the drug label of maple gastroenteric preparation
4.
Revision requirements for the drug label of the spleen and raising children
Revision requirements for the drug label of the spleen and raising children
State Food and Drug Administration
December 28, 2022
