CCTV News: The State Food and Drug Administration issued an announcement on revising the instructions for the preparation of ranitidine hydrochloride injection (No. 49 of 2025). According to the results of adverse drug reaction evaluation, in order to further ensure the safety of public drug use, the State Food and Drug Administration decided to uniformly revise the instructions for ranitidine hydrochloride injection preparations (including: ranitidine hydrochloride injection, ranitidine hydrochloride for injection, and ranitidine sodium chloride injection). The relevant matters are now announced as follows: 1. The marketing authorization holders of all the above-mentioned drugs shall revise the instructions in accordance with the "Drug Registration Management Measures" and other relevant regulations, in accordance with the requirements of the attached documents, and submit them to the provincial drug supervision and administration department for filing before August 12, 2025.
If the revision content involves drug labels, 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 registration shall not continue to be used in the original drug instructions. The drug marketing authorization holder shall replace the drug instructions and labels that have been shipped out of the factory within 9 months after filing, or inform the patient of the update information of the instructions in other forms.
2. Drug marketing authorization holders should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to promote and train drug use and safety issues, and guide doctors and pharmacists to use drugs reasonably.
3. Clinicians and pharmacists should carefully read the revisions of the above drug instructions. When choosing medication, they should conduct sufficient benefits/risk analysis based on the newly revised instructions.
4. Patients should carefully read the drug instructions before taking the medication. If they use prescription drugs, they should strictly follow the doctor's instructions.
5. Provincial drug supervision and administration departments shall urge the marketing authorization holders of the above-mentioned drugs in the administrative area to do a good job in revising the corresponding instructions and informing the relevant instructions labels, replacement of instructions and updating instructions as required, and severely investigate and punish illegal and irregular acts in accordance with the law.
