Abstract: Objective To provide a new "people-oriented" thinking on Rx-OTC switch review process for our country. Methods By studying consumer behavior studies in the U.S., introduce three research tools: label comprehension studies, self-selection studies, consumer actual use studies, compare these three tools and their relationship, summarize the importance of consumer behavior studies in Rx-OTC switch. Results Bringing consumer behavior studies into Rx-OTC switch contributes to pharmaceutical manufactarers on drug switch, and thus as a new OTC status in the market. Conclusion American "people-oriented" new thinking is worth concerning seriously for our regulatory review division and pharmaceutical manufactarers.

Key words: OTC, switch, consumer behavior, people-oriented