A Comparative Analysis of Chinese and US Government Approaches to Managing Generic Drug Quality

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The Ohio State University

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This article examines and compares the methods used to ensure generic drug quality management in China and the United States, two countries with important influence in the global pharmaceutical market. From a historical and economic point of view, the unique development processes of the two countries have resulted in different generic drug review processes. China developed later than the U.S. and continues to lag in policy issuance and implementation. However, judging from a review of the historic and current processes of generic drug approval and monitoring, China has greatly improved since 2015. In comparison, the U.S. has a relatively stable review process with continuous adjustments by the government and Food and Drug Administration from the 1980s. When comparing the specific cases of the two countries, there are clear differences in the distribution and implementation of the power of enforcement between China and the U.S. Through a combination of policy analysis, literature review, and case studies, the findings illustrate the strategies adopted by the Chinese and U.S. governments to ensure the safety and quality of generic drugs that are largely similar, but in some cases have unique details based on national circumstances.



Generic Pharmaceuticals, Generic Drug Quality, Pharmaceutical Regulatory Policies, China-US Generic Drug Regulation