Survey of the Regulation System of OTC Drugs in the United States

doi:10.19803/j.1672-8629.2021.02.09

Abstract

Abstract: Objective To provide reference for the improvement of regulation of OTC drugs in China by analyzing the related laws and regulations concerning OTC drugs in the United States. Methods By consulting the official website and literature of the US drug regulatory departments, the author analyzed the progress in the US OTC drug marketing system and procedures, prescription drug conversion, OTC drug labeling and supervision of advertisements. Ways to promote the supervision of China' s OTC drugs were also recommended. Results OTC monograph path saves review resources, improves regulatory efficiency, and speeds up the listing of OTC drugs.in the USA. At the same time, it actively modifies the monograph process to deal with the backlog of monographs and inefficient review. Conclusion It is recommended that marketing methods of OTC drugs be diversified in China by learning from the United States. We should innovate the post marketing supervision of OTC drugs, bring into full play the role of industry associations, tighten the control over OTC advertising, and help consumers learn more about drug use.

Key words: the United States, over-the-counter drugs, regulations, monograph, labeling, adverse drug reaction

CLC Number:

R951

XU Shungui, LIU Chunguang. Survey of the Regulation System of OTC Drugs in the United States[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 141-144.

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