NMPA Announcement on Revising the Package Insert of Methimazole Preparations
To further protect public medication safety, the NMPA decided to revise the package insert of Methimazole Preparations. The relevant issues are hereby announced as follows:
I. The marketing authorization holder of this product shall, in accordance with the Provisions for Drug Registration and the revision requirements for the package insert of methimazole preparations, submit a supplementary application as such before May 3, 2021 to the Center for Drug Evaluation of NMPA or provincial drug regulatory department for filing.
If the revision involving the drug label, the label shall be revised together; the other content of the package insert and the label shall be consistent with the original approved ones. For drugs produced since the date of filing, the original package insert shall not be used any more. All the package inserts and labels of ex-factory drugs shall be changed within 9 months after the said revision had been filed by the drug marketing authorization holder.
II. The drug marketing authorization holder 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, and notify the drug distributor and end-user units in an appropriate and timely manner if the medication safety-related content are changed, to guide the physician and pharmacist to use the medicine rationally.
III. The clinicians and pharmacists shall carefully read the revised content of the package inserts for methimazole preparations. 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.
V. Provincial drug regulatory departments shall urge the drug marketing authorization holders of the product within their respective jurisdiction to revise the package inserts, change the labels and package inserts as required and impose severe punishment in accordance with law if violations of laws and regulations happen.
It is hereby announced.