摘要
药械组合产品是由药品、生物制品、医疗器械三者之间任意组合的一类新型医疗产品。由于该类产品包含了隶属于不同监管部门的传统组成部分,这给产品监管、政策的制定以及审评管理带来了一定的挑战。本文介绍了美国、欧盟对药械组合产品的分类管理、审评模式,分析了我国药械组合产品管理现状及存在的问题,并且对该类产品的监管提出一些初浅的意见和建议。
A combination product is a new type of medical product composed of any combination of a drug, a device and/or a biological product. Because combination products involve components that would normally be regulated under different types of regulatory authorities, they raise challenging regulatory, policy, and review management challenges. This article introduces the classification management and review mode of combination products in US and Europe, analyses the current situation of combination products management in China, and provides comments and suggestions on supervision of this new product type.
出处
《中国医疗器械信息》
2009年第8期50-52,95,共4页
China Medical Device Information
关键词
药械组合产品
分类管理
首要作用模式
联合审评
监管对策
combination products, classification management, PMOA, intercenter review, supervisory measures
