The consideration behind America's Advancing process of OTC marketing pathway [美国非处方药上市路径演进背后的监管考量]

作者：Tang T.-Y.; Wu Y.-F.; Yang P.; Li J.-R.; Yang Y.; Xing H.

来源：中国新药杂志, 2022, 31(24): 2429-2436.

• Advancement of institution
• Direct-to-OTC
• Non-prescription/over-the-counterdrug
• OTC monograph pathway
• Regulatory consideration
• Rx-to-OTC Switch

In order to optimize the OTC drug marketing path and enrich the choices of self-medication for Chinese civilians, this paper reviewed the development of OTC drug marketing path in the United States from two dimensions: history and status quo, aiming to find out the regulatory consideration behind the establishment of the Direct-to-OTC pathway, the monograph pathway and Rx-to-OTC switch pathway, and enlighten the future work of the OTC reform in China.

• 单位
  清华大学