美国和日本非处方药专论路径研究及对我国的启示

Study on the Process of Over-the-counter Drugs in the United States and Japan and the Implication for China

目的:探讨我国建立非处方药专论路径的可行性。方法:采用文献研究法和对比分析法,对比美国和日本非处方药专论路径的出台背景、主要内容以及专论制定程序等,分析美国和日本专论路径的风险管控措施。结果:美国和日本针对低风险产品建立专论路径,体现了基于风险对药品实施分类管理的理念,以专论建立过程中的有效风险管控为前提,简化专论产品上市的审评审批,有利于节约审评资源,提高监管效率,更好地满足公众的用药需求。结论:建议借鉴美国和日本的经验,开展我国非处方药专论路径的试点工作。

Objective: To explore the feasibility of establishing the OTC drug monograph process in China. Methods: To introduce background and main content of the OTC drug monograph process, as well as monograph establishment procedures in the United States and Japan were compared by literature research and comparative analysis, and the risk control measures of the US-Japan monograph process were analyzed. Results: The establishment of monograph process for low-risk products in the United States and Japan reflects the concept of classification management of drugs based on risk. On the premise of effective risk management and control in the process of monograph establishment, simplifying the review and approval of monograph products is beneficial to economize review resources, improve regulatory efficiency, and better meet the public’s requirement for OTC drug. Conclusion: It is recommended to draw on the experience of the United States and Japan to carry out pilot work on the OTC monograph process in China.