补充申请增加规格常见问题分析

Main problems and analysis of additional specifications in the supplementary application

增加规格是一类较为常见的补充申请。申请人由于对这类变更研究的理解不够深入,前期研究存在不足,常常需要在申报过程中补充研究资料。研究资料缺陷较为严重的补充申请甚至不被批准。为了更好地提高研发和评价效率,本文整理了补充申请增加规格中的常见问题,并加以分析,以供研究者参考。

Additional specifications are more common supplemental application.Due to the applicants understanding of such changes is often not deep enough,and defects exist in preliminary studies.Therefore,the supplemental applications can frequently not be approved.In order to improve efficiency of the development and evaluation,this article summarized and analyzed the frequently asked questions in supplemental application of additional specifications.