The State Food and Drug Administration recently issued an announcement on the revision of the drug instructions for enteritinium preparations, indylan oral preparations and ginkgolide injections, the full text of which is as follows
.
1.
Where the content of the revision involves the label of the drug, it shall be revised together; The instructions and other contents of the label shall be consistent
with the original approved content.
Second, the holder of the drug marketing authorization shall conduct in-depth research on the mechanism of the occurrence 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 and patients to use drugs reasonably
.
Third, clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct full benefit/risk analysis
according to the newly revised instructions.
Fourth, patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's instructions
.
V.
This is hereby announced
.
Annex:
1.
2.
3.
4.
State Food and Drug Administration
May 20, 2022
According to the results of the assessment of adverse drug reactions, in order to further ensure the safety of public medication, the State Drug Administration decided to uniformly revise
the [adverse reactions], [contraindications] and [precautions] of the drug instructions such as enteritidin preparation, Yinyuan Huang oral preparation and ginkgolide injection.
1.
Where the content of the revision involves the label of the drug, it shall be revised together; The instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced from the date of filing shall not continue to use the original drug instructions
.
The holder of the drug marketing authorization shall replace the drug instructions and labels that have been shipped from the factory within 9 months after filing
.
Second, the holder of the drug marketing authorization shall conduct in-depth research on the mechanism of the occurrence 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 and patients to use drugs reasonably
.
Third, clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct full benefit/risk analysis
according to the newly revised instructions.
Fourth, patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's instructions
.
V.
The provincial-level drug supervision and administration department shall promptly urge the drug marketing license holders of the above-mentioned drugs in the administrative region to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
This is hereby announced
.
Annex:
1.
Enteritramin preparation prescription drug instructions revision requirements
2.
Enteritidin preparation over-the-counter drug specification revision requirements
3.
Revised requirements for the instructions of the oral preparation of Yinyuan Huang
4.
Ginkgolide injection instructions revision requirements
State Food and Drug Administration
May 2022, 5
