Home> Regulatory Information

NMPA Announcement on Regulating Weian Capsules as Non-prescription Drugs

CCFDIE|Updated: 2021-02-01

     

According to the Provisions for the Classification Management of Prescription and Non-prescription Drugs (Interim), after the demonstration and review organized by the NMPA, the Weian Capsules are approved to be regulated as non-prescription drugs.

Before April 25, 2021, the drug marketing authorization holder shall, in accordance with the Provisions for Drug Registration and other relevant provisions, submit the revised package insert of drug to the provincial drug regulatory department for filing and in a timely manner inform relevant medical institutions, drug distributors and other units of the revised content in the package insert of drug.

For the content in the package insert of drug other than that specified in the template of the package insert of nonprescription drugs shall be revised in accordance with original approval document. Drug labels involving content related to the above revision shall be revised together. For drugs produced since the date of filing, the original package insert shall not be used any more.