Announcement of the State Food and Drug Administration on Revising the Instructions for Benzbromarone Oral Preparations (No. 150 of 2020)

In order to further protect the safety of public medication, the State Drug Administration has decided to revise the instructions for benzbromarone oral preparations
.
The relevant matters are hereby announced as follows:

1.
All manufacturers of benzbromarone oral preparations shall submit supplementary applications for the revision of the instructions in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations and in accordance with the requirements for the revision of the instructions for benzbromarone oral preparations (see appendix).
Report to the Drug Evaluation Center of the State Drug Administration or the provincial drug regulatory authority for record before 28th
.

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

The manufacturers of benzbromarone oral preparations 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 the drug management and use of changes in content related to drug safety.

2.

3.

Hereby announce

Attachment: Requirements for the revision of the instructions for benzbromarone oral preparations

State Food and Drug Administration

December 29, 2020