Announcement of the State Food and Drug Administration on Amending the Instructions for Clodronate Disodium Preparations (No. 135 of 2021)

According to the evaluation results of adverse drug reactions, in order to further ensure the safety of public medication, the State Drug Administration has decided to uniformly revise the contents of the instructions for clodronate disodium preparations. The relevant matters are hereby announced as follows:

1. The marketing authorization holders of the above-mentioned drugs should report to the State Drug Administration before February 21, 2022 in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and in accordance with the requirements for the revision of the instruction manual of clodronate disodium preparations (see attachment). It should be filed with the Drug Evaluation Center or the provincial drug regulatory department.

If the revised content involves the drug label, it shall be revised together; the instructions and other contents of the label shall be consistent with the original approved content. Drugs produced from the date of filing shall not continue to use the original drug inserts. The drug marketing authorization holder shall replace the package insert and label of the drug that has already left the factory within 9 months after filing.

2. The drug marketing authorization holder shall conduct in-depth research on the mechanism of newly added adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety issues, and guide physicians and pharmacists to rationally use drugs.

3. Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug insert sheets, and when choosing medication, they should conduct adequate benefit/risk analysis according to the newly revised insert sheets.

4. Patients should read the instructions carefully before taking medicines, and those who use prescription drugs should strictly follow the doctor's instructions.

5. Provincial-level drug regulatory authorities shall urge the drug marketing authorization holders of the above-mentioned drugs within their administrative regions to do a good job in revising corresponding instructions and replacing labels and instructions as required, and strictly investigate and punish violations of laws and regulations in accordance with the law.

Special announcement.