美国非处方药专论制度介绍及对我国的启示

Introduction of OTC Monograph System in USA and Its Enlightenment to China

目的:为我国实施非处方药(OTC)专论提供参考。方法:采用文献研究法对美国OTC专论的概念、产生与发展历程以及作用等进行全面梳理;借鉴美国经验,探究专论制度对于OTC注册审评的必要性及在当前我国的可实施性,并提出我国实施OTC专论的几点建议。结果与结论:美国OTC专论是指在销售不包含在新药申请中的OTC产品时应遵循的监管标准,其源于OTC有效性再评价工程,在加速药品上市、促进产品创新方面发挥了特殊作用;OTC专论制度对于优化OTC注册审评具有必要性,但是目前我国尚不具备建立和实施OTC专论的条件,尚需在优化资源配置和基础设施、结合本国OTC管理经验和特点的基础上,才能充分发挥OTC专论在OTC注册审评中的作用,具体可从开展对药品专论深入研究、试点检验专论成效、完善风险管理体系、优化审评资源配置等方面推进。

OBJECTIVE:To put forward some suggestions for the implementation of OTC monograph in China.METHODS:Literature research was used to comprehensively review the concept,emergence and development,function of OTC monograph in USA;referring to experience in USA,the necessity and feasibility of monograph system for OTC registration and evaluation in China were explored,and some suggestions were put forward to the implementation of OTC monograph in China.RESULTS&CONCLUSIONS:OTC monograph in USA refers to the regulatory standards that should be followed when selling OTC products not included in new drug applications.The monograph originates from the re-evaluation project of the effectiveness of OTC drugs,which plays a special role in accelerating the drug marketing and promoting product innovation.The OTC monograph system is necessary to help to optimize the OTC registration and evaluation,but at present,the conditions to establish and implement OTC monograph are not yet ripe in China.Based on the optimization of resource allocation and infrastructure construction,national OTC drug management experience,OTC monograph can play a full part in OTC registration and evaluation,in terms of carrying out in-depth research,taking pilot test,improving risk management system and enhancing drug review resource allocation ability.