To further protect public medication safety, the NMPA decided to revise the package insert of Misoprostol Tablets for obstetrical and gynecological application. Relevant issues are hereby announced as follows:

I. The marketing authorization holders of this product shall, in accordance with relevant provisions such as the Provisions for Drug Registration, submit the supplementary application for revising the package insert according to the requirements for revising the package insert of Misoprostol Tablets for obstetrical and gynecological application, and report to the Center for Drug Evaluation of NMPA or provincial drug regulatory authorities for filing prior to May 24, 2021.

Where the content of revision involve the drug label, the label shall be revised along with all the others; the package insert and other contents of the label shall be consistent with those originally approved. For the drugs manufactured as of the date of filing, the original package insert of the drug shall not be used any more. The drug marketing authorization holder shall replace all the package inserts and labels of ex-factory drugs within 9 months after filing.

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 immediately notify the drug distributor and user facilities in an appropriate manner if the medication safety-related contents are changed, to guide physicians and pharmacists to use the drug rationally.

III. Clinicians and pharmacists shall carefully read the revised content in the package insert of Misoprostol Tablets for obstetrical and gynecological application; in the selection of drugs, comprehensive benefit/risk analysis shall be made based on the newly revised package insert.

IV. Patients shall carefully read the package insert prior to medication, and strictly comply with the medical orders.

V. Provincial drug regulatory departments shall urge the drug marketing authorization holder of this product within their jurisdiction to revise the package insert and replace the labels and package insert as required, and shall severely investigate and punish the violations of laws and regulations in accordance with law.

It is hereby announced.