Analysis and Suggestions on Main Measures of Risk Management in National Drug Sampling and Testing / 中国药学杂志

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.

Research on the Applicability of Drug Quality Standards in National Drug Sampling and Testing / 中国药学杂志

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.

Analysis and suggestion on effect of drug safety regulatory during national drug sampling and testing / 中国药学杂志

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.