摘要
近年来,医用妇科凝胶产品的注册申报数量增多,但该类产品目前缺少针对性的国家标准和行业标准,导致审评工作的标准化程度低.该研究首先介绍医用妇科凝胶产品概况,然后基于医用妇科凝胶产品生产企业调研情况并结合既往该类产品的技术审评经验,从产品名称、注册单元划分、非临床资料、临床资料、说明书和标签样稿等方面总结其技术审评要点,以期为产品注册申请人和相关审评人员提供参考.
Abstract
In recent years,with the increase in the number of registration applications for medical gynecological gel products,there is currently a lack of targeted national standards and industry standards for this type of product,leading to a low degree of standardization of the review work.In this study,based on the survey of medical gynaecological gel product manufacturers,combined with previous experience in technical review of this type of product,first,medical gynecological gel product overview was introduced;Then,the technical review of this type of product was summarized from the aspects of product name,registration unit division,non-clinical data,clinical data,instructions,and label samples,in order to provide reference for product registration applicants and relevant reviewers.
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