我国处方药与非处方药转换的阶段性特点分析.pdfVIP

中国药物警戒第10卷第5期 2013年5月 May, 2013, Vol.10, No.5 中图分类号：R951 文献标识码：A 文章编号：1672-8629（2013 ）05-0278-05 ·政策与法规研究· 我国处方药与非处方药转换的阶段性特点分析 * 汤韧 夏东胜 田春华 王春婷 （国家食品药品监督管理总局药品评价中心 ，北京 100045 ） 摘要：目的 按不同阶段特点对我国处方药与非处方药转换情况进行汇总，为转换技术评价提供参考。 方法 收集处 方药与非处方药转换的相关法规、技术标准以及公布 品种的情况，分析其阶段性特点。 结果与结论 随着我国药品监 管的整体发展，处方药与非处方药转换的法规和技术标准逐步完善 。 现有法规和技术标准能较好地指导非处方药的 研发、申报及评价，但在某些方面仍需改进。 关键词：处方药；非处方药；转换；进展 Stage Characteristics of Prescription and Nonprescription Switch in China * TANG Ren XIA Dong-sheng TIAN Chun-hua WANG Chun-ting (Center for Drug Reevluation, CFDA, Beijing 100045, China) Abstract: Objective To summarize characteristics of prescription drugs and nonprescription drugs switch in China by stage and to provide reference for the technical evaluation of the switch. Methods Collecting the regulations, technical norms and varieties released in prescription drugs and nonprescription drugs switch and analyzing the stage characteristics. Results and Conclusion With the general development of drug administration in China, the regulations and technical norms of prescription drugs and nonprescription drugs switch are being improved. The current regulations and technical norms are were suit for the development, application and evaluation of nonprescription drugs, but some improvements are still needed. Key words: prescription drugs; nonprescription drugs; switch; progress 处方药是必须凭执业医师或执业助理医师处方才可 药与非处方药的转换公布 了一系列法规文件、工作程序 调配、购买和使用的药品；非处方