To further protect public medication safety, the NMPA decided to revise the package inserts of Sulfasalazine Preparations. The relevant issues are hereby announced as follows:

1. All manufacturers of Sulfasalazine Preparations shall, in accordance with the Provisions for Drug Registration and relevant requirements, based on the instruction of the revised Package Inserts of Sulfasalazine Preparations, submit a supplementary application as such before April 12, 2021 to the Center for Drug Evaluation, NMPA or corresponding provincial drug regulatory department for filing.

If the modification relates to the label of the drug, the latter shall be modified together; the other content of the package insert and the label shall be consistent with the original approved ones. All the insert sheets and labels of exfactory drugs shall be changed within 9 months after the record filing of the supplementary application.

The manufacturers of Sulfasalazine Preparations should 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 distributors and end-user units in an appropriate and timely manner if the medication safety-related contents are changed, to guide the physician and pharmacist to use the medicine rationally.

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

3. The patients should carefully read the newly modified package inserts before use, and strictly comply with the medication orders.