Discussion on the Quality Risk Reminder Mechanism of Drug Sampling and Testing in China / 中国药房

ABSTRACT

OBJECTIVE：To provide a reference for further improvi ng the quality risk reminder mechanism of the drug sampling and testing （called“the Reminder ”as for short ）in China ，and strengthening the drug quality management. METHODS ： The quality risk management situation of the drug sampling and testing were summarized ，and the legal nature ，main content and working procedures of the Reminder were analyzed. The latest data of the Reminder in 2020 were taken as an example to analyze the role of the Reminder in the investigation of potential drug quality risks ，and made the suggestions for existing problems. RESULTS & CONCLUSIONS ：Based on legal standards ，China’s drug regulatory departments had carried out exploratory research on drugs that may have quality and safety risks due to drug quality control blind spots or deviations of manufacturing enterprises ， and divided them into serious risks and general risks according to the severity of the problems found ，and implemented hierarchical management. The Reminder was an administrative measure for general drug quality risks based on the principle of persuasion first ， and did not have sanctions. Its main content covered all the information required for risk investigation and rectification （basic drug information， suggested risk information ， contact information ， risk discovery methods ， troubleshooting and rectification requirements，and responsibilities of local provincial drug regulatory departments ）. It involved five responsible parties ，ie. the inspection institution ，China Institute for Food and Drug Control ，National Medical Products Administration ，the provincial food and drug administration of the relevant manufacturing enterprises and the relevant manufacturing enterprises. Through the mode of closed-loop management ，the benign interaction between regulatory authorities and manufacturing enterprises could been realized. In 2020，National Medical Products Administration issued 312 reminders to 286 manufacturers，with an accuracy of 87.91％，which was scientific and targeted. The manufacturer had carried out a series of rectification measures for the contents of the Reminder ， including carrying out process verification ，revising internal control standards and strengthening production process control. However， there were also some problems ， such as the rationality of the prompt contents being questioned by the manufacturer and the i nsufficient investigation of the manufacturer. It is suggested that the manufacturers correctly understand the nature and value of the Reminder. The inspection agency should further improve the scientific pertinence of the problems found ，while the drug regulatory department should focus on the troubleshooting of the problems found ，so as to jointly promote the improvement of drug quality.