Lifecycle Management of American Drug Labeling and Its Implication

Abstract

Abstract: Objective To put forward suggestions for improving drug labeling regulatory system and establishing a dynamic management system for drug labeling. Methods By studying American laws, regulations and guidelines of drug labeling, its scientific points were analyzed. Results and Conclusion It was suggested that we should learn the management pattern of America, improve the legal system of drug labeling in China, strengthen the classification management of labeling, set different labeling types based on different readers, improve the post-market drug labeling revision procedure. Generic drugs labeling should be consistent with new drugs labeling in principle. Penalties for drug labeling violation should be enhanced in order to promote the initiative of drug companies to revise labeling, accelerate the update of drug labeling, and finally form a dynamic adjustment mechanism throughout the drug lifecycle.

Key words: drug labeling, lifecycle management, regulatory system

CLC Number:

YU Jin-ran, WANG Hong-wei, WANG Yi-fang, YANG Yue. Lifecycle Management of American Drug Labeling and Its Implication[J]. Chinese Journal of Pharmacovigilance, 2018, 15(6): 333-338.

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