FDA reform of inspection agency by product types and its enlightenment / 国际药学研究杂志

ABSTRACT

This article takes FDA reform of inspection agency by product types as the research object, analyzes its content and characteristics, and discusses the implementation effects with the statistical data based on the number of FDA warning letters is sued. The results of the analysis revealed that the number of warning letters issued increased while the interval between inspection and issuing warning letters decreased, which indicated that the FDA inspection and enforcement activities became more effective and effi cient. For further improvement of the drug administration in China, we need to improve the classification of product-based inspection force, and strengthen the interdepartmental coordination.