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

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.