| Abstract Objective: To provide references for improving sampling and testing system and exploring the quality risk control model of generic drugs in China. Method: Documentary research was utilized to collect and analyze the laws, key regulations, annual reports (2008~2019), which were related to the generic drugs quality surveillance. Result: Japan has established a manage system based on the generic drugs information workshop, prepare the lists of products by a risk-bias approach, constructed a unified operation network to sample and test the products, built the quality evaluation framework involving all the arena relating to generic drugs. Conclusion: As the efficacious extention to generic drug revaluation project, with a complete system, sampling and testing program of generic drugs has grown to a risk control approach base on the generic drugs information workshop. Learning from experience, China should lay the coordination plate between consistency evaluation and sampling and testing system, involve more experts in generic drugs, set up profiles of tested products to monitor the samples that were hard to get. |