An Overview of Recent Developments in the European Regulation of Medicine/Medical Device Combination Products

被引：0

作者：

David B. Jefferys

机构：

[1] Hannibal House,Medical Devices Agency

[2] Elephant and Castle,undefined

来源：

Drug information journal : DIJ / Drug Information Association | 2003年 / 37卷

关键词：

Medical device regulations; Combination products; Tissue engineering; Drug delivery systems; Theranostics; Harmonisation; New approach directives;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

This article reviews the recent changes in the development and regulation of medicine/medical device combination products. It considers the impact of recent technological advances, particularly in the areas of theranostics and tissue engineering, upon the regulations. Suggestions are made as to how companies should approach such interface products. The current debate on the future regulation of tissue-engineered products is also discussed.

引用

页码：39 / 43

页数：4