Formation Analysis and Actual Challenges of National Drug Sampling and Testing Program from the Perspective of Risk Management

OBJECTIVE To review and summarize the formation and current situation of national drug sampling and testing program from transition of laws and regulations,institutional changes,utilization of policy instruments based on the concept of risk management,and analyze the actual challenges and possible strategies in the post-pandemic era.METHODS The literature research method was used to summarize the national laws,regulations and policies related to drug sampling inspection,past archives,procedural documents and research literature,and the changes in the risk management system and the use of policy tools at various stages was analyzed.RESULTS The formation of national drug sampling and testing program could be divided into five phases,by years of development,the goal of national drug sampling and testing program had been transferred from controlling counterfeit drugs to contributing the high-quality development of pharmaceutical industry.The legal framework was growing to cover the whole sampling and testing system.The way of testing also had became to find the potential quality risk by exploratory research,instead of merely testing the products by quality standards.CONCLUSION The quality risk management system built by the national drug sampling and testing program has complete the historic tasks in all phases.However,the system still faces to the challenges such as the growing complexity of drug supply chains,isolated data regulation mode and how to construct the mechanism of monitoring drug quality in clinical oriented model.