In accordance with the results of adverse drug reaction assessment, to further guarantee the safety of people in the use of drug, the NMPA decided to revise such items as [Adverse reactions], [Contraindications] and [Precautions] in the package inserts of antiviral syrup, capsules, soft capsules, pills (concentrated pills), dropping pills, tablets, effervescent tablets, chewable tablet, oral liquid, and granules. The relevant issues are hereby announced as follows:

I. The marketing authorization holders of the said products shall, in accordance with the Provisions for Drug Registration and the revision requirements for the package insert (see Attachments 1 and 2) of antiviral syrup, capsules, soft capsules, pills (concentrated pills), dropping pills, tablets, effervescent tablets, chewable tablet, oral liquid and granules (both prescription drugs and OTC), file a report as such before December 27, 2021 to provincial medical products regulatory authority.

Where the contents of revision involve the drug label, the label shall be revised along with all the others; the other contents of the label and package insert shall be consistent with those originally approved. For the drugs produced from the date of filing, the original package insert shall not be used any more. All package inserts and labels of ex-factory drugs shall be changed within 9 months after the said revision had been filed by the marketing authorization holder of drug.

II. The marketing authorization holder of drug shall conduct in-depth research on the occurrence mechanism of new adverse reactions, take effective measures to publicize the training on drug use and safety issues, to guide the physician, pharmacist and patient to use the medicine rationally.

III. The clinicians and pharmacists shall carefully read the revised contents of said package inserts. Drug options should be based on comprehensive benefit / risk analysis as per the new revisions. 

IV. The patients should carefully read the package inserts before medication, and strictly comply with the medication orders for prescription drugs. 

V. Provincial medical products regulatory authorities shall urge the drug marketing authorization holders of the product within their respective jurisdiction to revise the package inserts and replacement of the labels and package inserts as required and impose severe punishment in accordance with the law for violations of laws and regulations. 

It is hereby announced. 

(Attachment: omitted)