浅谈对药械组合产品属性界定的认识和建议

药械组合产品,是一种由药品和医疗器械组合而成的医疗产品。对这类产品的监管,首先需要确定产品的管理属性,即按药品还是按医疗器械管理。由于我国对药械组合产品的监管处于起步阶段,相关的法规尚不完善,涉及到产品属性界定的相关规定较为笼统,特别对界定属性资料没有具体明确的要求。本文在分析现有相关法规的基础上,借鉴美国FDA在组合产品管理方面的经验,结合我国药品和医疗器械监管的特点,就如何认识药械组合产品属性界定,以及明确界定属性的资料要求,提出初浅的意见和建议。

Researches and Suggestions of Jurisdictional Designation of Combination Products

Combination products are novel medical products that combined drugs and devices.As far as the regulation of combination products is concerned,firstly the classification and jurisdiction should be decided,in other words,which administration,drugs or medical devices,the combination product would be designed to should be decided.In our country,the regulating for combination products is in its primary stages and regulatory system has not been established completely.Therefore,some provisions about classification and jurisdiction are general and there are no specific requirements for application materials.In this article,based on the issued legislation and adapted the experience of combination products regulation of FDA,we bring up some suggestions to regulate the designation of combination products and specify the requirements.