Analysis and Enlightenment of the American Drug Quality Sampling and Testing Management

OBJECTIVE To analyze the key points of American management of drug quality sampling and testing, and provide reference for the drug administration of China. METHODS Literature research and data analysis were conducted, relevant literatures were consulted, and the official website of FDA was retrieved to find documents related to drug quality sampling and testing, the data disclosed in the annual report of the drug sampling and testing between 2013 and 2017 were summarized, and the regulatory strategies revealed in American drug quality sampling and testing were researched. RESULTS The Compliance Program Guidance Manual for drug quality sampling and testing was established, the risk-based selection criteria was constructed, work cohesion seamless integration of surveillance, review, inspection and data sharing was emphasized in American. CONCLUSION The regulatory experiences of American drug quality sampling and testing, are still useful for the advancement of regulatory science, and further improvement of scientific and targeted nature of drug sampling and testing in China.