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.
ABSTRACT
OBJECTIVE: To analyze the main measures of the drug quality and safety risks management in the national drug sampling and testing, and provide reference for improving the drug sampling and testing after listing. METHODS: Using retrospective research methods to analyze the effects of the deadline management, special item (special topic) sampling and testing, serious quality risk disposal mechanism, nonserious quality risk warning mechanism, information disclosure on drug quality and safety risk management during the national drug sampling and testing in 2014-2019. RESULTS: A series of measures improved a timely, efficient and complete closed-loop response chain of risk identification-disposal-disclosure. CONCLUSION: The main measures can help reduce public drug safety risks and have good demonstration and guiding significance for local drug sampling and testing. It is recommended to continuously improve the risk management mechanism, such as learning from the US and EU drug regulatory experience, strengthening the sampling and testing of vaccines, imported drugs and consistency evaluated drugs, and personalized designing test and research strategies.
ABSTRACT
OBJECTIVEP: To provide a reference to improve the information disclosure of drug sampling and testing. METHODS: Through literature and information disclosure measures research, combined with examples, the historical evolution, disclosure form, disclosure status, and significance of the drug sampling and testing results disclosure in China was analyzed, suggestions was made. RESULTS: AND CONCLUSION: The disclosure of drug sampling and testing results are helpful to improve the government's credibility, protect the public's right to know, deter illegal enterprises and promote the improvement of drug quality. It is suggested that the drug regulatory department learn from the FDA's experience to improve the legal status of information disclosure, strengthen timeliness, transform results, monitor public opinion and remove the enterprise information from public environment after credit repair,and all circles of society correctly understand and rationally treat the information disclosure content, in order to improve the information disclosure of drug sampling and testing and promote the social co-construction and co-governance of drug quality and safety.
ABSTRACT
In the process of supervision, the manufacturer often denies manufacturing the unqualified Chinese herbal pieces sampled from the seller and user. In response to this problem, this article reviews the policies and regulations for drug traceability, collects the denial manufacture of the unqualified Chinese herbal pieces by the labeled manufacturers from the national drug quality announcement, identifies the risks and critical control points with the risk management tool HACCP of ICHQ9. It is recommended to improve the legal system and traceability system for Chinese herbal pieces, investigate the source of the product involved thoroughly, strengthen the supervision of the TCM markets, sellers and users, and punish the illegal behavior jointly, which provides a reference for solving the problem.
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OBJECTIVE: To provide a reference to the use of quality standards in national drug sampling and testing, and establish the implementation plan. METHODS: By carding the approval process and usage flow of drug standards, analyzing approval form, authorized department, revise and numbering methods of the standard, composition and influencing factors of standard serviceability were studied. RESULTS AND CONCLUSION: The correctness and accuracy of the quality standards have a tremendous impact on national drug sampling and testing which is a significant measure of post-marketing surveillance. The article focuses on three aspects including the correctness, accuracy and orderliness, and then some solutions are proposed such as establishing the implementation plan and multi sector coordination, which can solve the problem of using standards in national drug sampling and testing.
ABSTRACT
OBJECTIVE: To improve the method of national drug sampling and testing system, Enhance the work efficiency of national drug sampling and testing, improve early warning ability of drug quality risk. METHODS: By using relevant data of national drug sampling and testing in the past 3 years, to analysis the tredency of drug quality situation. Through summarizing the effect of national drug sampling and testing work, put forward suggestions and countermeasures. RESULTS AND CONCLUSION: Strengthening efforts on sampling and testing, improving the efficiency by using varied and flexible sampling form, enhancing the application effects of sampling and testing through multi forms and channels, further perfect drug quality announcement releasing mechanism, enriching the form and content of drug quality announcement, increasing the interpretation and analysis of sampling data, in order to enhance the effective cohesion between the sampling and testing work and supervision management.