开展仿制药质量一致性评价的探讨

2012年1月20日，国务院下发的《关于印发国家药品安全“十二五”规划的通知》中要求开展仿制药一致性评价工作。本文概述我国仿制药质量存在的问题及其原因，提出开展一致性评价重点在于多条溶出曲线都要与原研药一致，旨在为进一步开展仿制药一致性评价工作提供建议。

Discussion on developing generics quality consistency evaluation

It is required to carry out generics quality consistency evaluation in the notice of the Twelfth Five-Year Plan of the national drug safety issued by the State Council on Jan 20, 2012. In this paper, we summarized the existing problems and causes of generic drug quality in China, and proposed that the key point of quality consistency evaluation is the consistency of multiple dissolution proifle between generics and brand-name drugs so as to provide some suggestions for further developing a work of generics quality consistency evaluation.