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。
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.Resultsand 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.
出处
《中国药物警戒》
2013年第5期278-282,共5页
Chinese Journal of Pharmacovigilance
关键词
处方药
非处方药
转换
进展
prescription drugs
nonprescription drugs
switch
progress
