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
This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.
Subject(s)
Equipment Safety , Equipment and Supplies , Industry , Reference StandardsABSTRACT
Objective: The medical equipment safety risks were avoided and reduce in clinical use. Methods: The security issues to may occur in the process of clinical diagnosis and treatment must be recognized on the multiple links of the medical equipment design, manufacture, management, and the user from the perspective of system security. From the causes of the formation of risk classification, risk assessment, and risk several aspects were analyzed, and work out preventive measures. Results:through the medical equipment quality and safety risk management, take appropriate measures to prevent the happening of the security risks, the influence of the safety risk factors is avoided and reduced. Conclusion:the medical equipment quality and safety risk problem involves many complicated factors, It must be strengthened the quality safety risk of the medical equipment comprehensive analysis, evaluation, management and control.