二类含壳聚糖敷料的现状及审评思考

Current Situation and Evaluation Considerations of Class II Chitosan Dressings

文章以“二类含壳聚糖敷料的现状及审评思考”为题,总结了我国已注册上市的二类含壳聚糖敷料的基本现状,分析了该类产品在注册审评阶段需关注的问题并提出了以下观点:①明确产品分类是产品申报中的首要问题;②壳聚糖原材料的控制是该产品质量控制的关键;③统一审评尺度对此类产品的注册和上市后监管具有重要意义。

This paper summariz‑ed the current situation of Class II chitosan dressings,and analyzed issues to be concerned during the registration and evaluation stage,proposed the following views:①Clarify the product classification is the primary issue in registration process;②The raw material control of chitosan is the key to the production quality control;③The unified evaluation scale is of great significance for the registration and post market supervision of these products.