药品再注册中存在的问题分析

Analysis of the problems existed in drug re-registration

目的:促进再注册工作的顺利进行,同时继续完善再注册工作,以更好的发挥其在药品监管中的作用。方法:通过学习国家食品药品监督管理局发布的相关法律法规及相关文献资料,对四川省2013年上半年化学药品再注册审批过程中存在的问题进行归纳和分析。结果:再注册工作需要监管部门及企业相关人员等多方的协同合作。

Objective： To promote the re-registration of drugs successfully, and continue to improve it for better development of its function in drug administration. Method： The existed problems in re-registration of chemical drugs in the first half of 2013 were summarized and analyzed with the guidance of the China Food and Drug Administration issued relevant laws and regulations and the relevant literature. Result： Re-registration of drugs need the efforts from registration commissioner and drug regulatory department.