Announcement of the State Food and Drug Administration on Revising the Instructions for Sulfasalazine Preparations (No. 7 of 2021)

In order to further protect the safety of public use of drugs, the State Drug Administration decided to revise the instructions for sulfasalazine preparations
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The relevant matters are hereby announced as follows:

1.
All manufacturers of sulfasalazine preparations shall submit supplementary applications for revision of the inserts in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations and in accordance with the requirements for the revision of the inserts of sulfasalazine preparations (see appendix), on April 12, 2021 It was reported to the Drug Evaluation Center of the State Drug Administration or the provincial drug regulatory authority for the record a few days ago
.

If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content
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All the instructions and labels of the medicines that have been shipped out of the factory shall be replaced within 9 months after the filing of the supplementary application

Sulfasalazine preparation manufacturers should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to conduct publicity and training on use and safety issues, and immediately notify drug dealers and users of changes in content related to drug safety in an appropriate manner , Instruct physicians and pharmacists to use drugs rationally
.

2.
Clinicians and pharmacists should carefully read the revised contents of the sulfasalazine preparation instructions, and when choosing drugs, they should conduct a sufficient benefit/risk analysis based on the newly revised instructions
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3.
The patient should strictly follow the doctor's prescription and read the instructions carefully before taking the medicine
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Hereby announce
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Attachment: 1.
Requirements for the revision of the instructions for sulfasalazine oral preparations

2.
Requirements for the revision of the instructions for sulfasalazine suppositories

State Food and Drug Administration

January 12, 2021

Announcement No.
7 of 2021 Annex 1.
doc of the National Medical Products Administration

Announcement No.
7 of 2021 Annex 2 of the State Drug Administration.