Analysis on the Situation of Drug Quality Risk Reminder Mechanism in China

OBJECTIVE To provide a reference for further improving the quality risk reminder mechanism of the drug sampling and testing in China. METHODS Introduced the drug quality risk reminder letter and the new drug quality risk situation in China, used the SWOT method to analyze the strengths, weakness, opportunities and threats of the reminder letter under the new situation, and conducted an overall evaluation of the reminder letter and put forward the improvement suggestions. RESULTS & CONCLUSION Recently, the drug quality is at a relatively high level, and the safety situation is generally stable and controllable in China, but non-serious risks still exist and cannot be eliminated. As an administrative measure for drug regulatory agencies to intervene non-serious risks based on the persuasion first principle, the reminder letter mechanism faces both internal and external advantages and disadvantages. It is suggested that the manufacturers further strengthen the use of reminder letters, and drug test institutes further provide technical support, and the drug regulatory department establish a failure remedial mechanism to continuously strengthen and improve the reminder letter mechanism.