我国非处方药上市路径调研与结果分析

Investigation and Result Analysis of the Marketing Paths of OTC Drug in China

目的:对我国非处方药上市路径的现状、存在的问题,以及国外非处方药上市路径管理模式对我国的适用性进行调研。方法:在前期文献研究的基础上,开展问卷调查,并对调查结果进行分析。采用非概率抽样法,选择从事化学药品OTC研发、注册、生产、经营的专业人员以及行业协会、监管机构的专家作为调研对象,以微信方式发放电子问卷进行调查。结果:调查结果表明,多数调查对象认为我国应建立符合我国国情的非处方药的专论制度,应完善我国处方药和非处方药的转换标准和程序以及非处方药的注册路径和审评程序。结论:本调研为进一步分析我国在非处方药上市准入管理方面存在的问题及完善建议提供了数据支持。

Objective: To investigate the current status and existing problems of OTC drug marketing paths in China, and the applicability of foreign OTC drug marketing path management models to China. Methods: On the basis of previous literature research, a questionnaire survey was conducted and the survey results were analyzed. The non-probability sampling method was used by selecting professionals engaging in chemical OTC drug R&D, registration, production and operation, as well as experts from industry associations and regulatory agencies being the respondents, and questionnaire surveys were conducted by issuing electronic questionnaires through WeChat. Results: The survey results showed that most respondents believed that China should establish OTC monograph system in line with China’s national conditions. The standards and procedures for the conversion of prescription drugs and OTC drugs as well as the registration path and review procedures of OTC drugs should be improved in China. Conclusion: This survey provides data support for further analysis of the problems in Chinese OTC drug market access management and suggestions for improvement.