China News Service, February 18. According to the website of the State Food and Drug Administration, the State Food and Drug Administration recently issued an announcement stating that according to the results of the adverse drug reaction assessment, in order to further protect the safety of the public’s medication, the State Drug Administration has decided to treat Liuwei Dihuang preparations ( (Including pills, capsules, tablets, mixtures, decoctions, granules) Instructions [Adverse Reactions] [Contraindications] and [Precautions] items will be uniformly revised.
According to the announcement, the marketing authorization holders of all the above-mentioned drugs shall revise the instructions in accordance with the relevant regulations such as the "Drug Registration Management Measures" and in accordance with the corresponding instructions for revision requirements, and report to the provincial drug regulatory authority for record before May 2, 2021.
The announcement pointed out that if the revised content involves the label of a drug, it should be revised together; other contents of the insert sheet and label should 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 instructions and labels of the drugs that have been delivered from the factory within 9 months after filing.
The announcement requires that drug marketing license holders should 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.
Clinicians should carefully read the revised contents of the above-mentioned drug inserts, and when choosing medications, they should conduct sufficient benefit/risk analysis based on the newly revised inserts.
Patients should read the drug insert carefully before taking the medicine, and if using prescription drugs, they should strictly follow the doctor's advice.
The announcement emphasizes that the provincial drug supervision and administration department should urge the drug marketing authorization holders of the above-mentioned drugs in the administrative area to do the corresponding instructions revision and labeling and replacement work as required, and strictly investigate and deal with violations of laws and regulations.