According to the official website of the State Drug Administration, in order to ensure the safety of drug use for the public, Weitongning Tablets, Huazhishishui Suppositories and Xiaoshuan Tongluo Preparations (tablets, capsules and granules) were organized and verified by the State Drug Administration in accordance with the Regulations on Classified Administration of Prescription and Non-prescription Drugs (Decree No. 10 of the State Drug Administration). ) The catalogue of OTC drugs is drawn up and managed according to prescription drugs. At the same time, the drug instructions mentioned above are revised. Relevant matters are hereby announced as follows:
1. The above-mentioned pharmaceutical manufacturing enterprises shall submit supplementary applications for the revised instructions in accordance with the relevant regulations such as the Measures for the Administration of Drug Registration and the requirements for the revision of the relevant drug instructions (see Annex 1-3) and submit them to the provincial drug regulatory authorities for the record by April 30, 2019.
Where the revised contents involve drug labels, they shall be revised at the same time; the instructions and other contents of the labels shall be consistent with the original approved contents. Within six months after the filing of the supplementary application, the manufactured drug instructions and labels shall be replaced.
The above-mentioned drug manufacturers should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job of propaganda and training on drug use and safety issues, and guide physicians to use drugs rationally.
2. Clinicians should carefully read the revised contents of the above-mentioned drug instructions and make full benefit/risk analysis according to the newly revised drug instructions when selecting drugs.
3. Patients should strictly follow the doctors instructions and carefully read the relevant drug instructions before using drugs.
4. The provincial drug regulatory departments shall urge the above-mentioned drug manufacturers in the administrative areas to do a good job in revising and replacing the corresponding instructions, labels and instructions according to the requirements; and organize strict investigation and punishment of illegal and irregular acts according to law.
I hereby announce.
Source: Wang Zheng_N7526, responsible editor of Beijing News