药械组合产品申报常见问题的思考

Consideration for the Common Problems of Combination Products Application

从技术评价角度,介绍药械组合产品的监管情况,结合近年来药械组合产品的审评情况,探讨药械组合产品技术审评的思路,以期对该类产品的申报注册提供参考借鉴。

This article summarizes the supervision conditions of the combination products and analyzes the common problems of these products application from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in these products registration.