透皮给药(TDDS)产品及法规概述

Overview of Transdermal Drug Delivery Products and Regulations

透皮给药领域因吸收、渗透限制,其上市产品与口服、注射用药市场占有率比较几乎是空白,因此本文总结美国、日本、欧盟以及我国透皮给药上市产品和主要企业,以及各国法规要求,为此类产品开发提供借鉴。

Due to the limitation of absorption and penetration in the field of transdermal drug delivery(TDDS),the market share of its marketed products is almost blank when compared with oral and injectable drugs.Therefore,this article summarizes the products and major companies of transdermal drug delivery in the United States,Japan,the European Union and China,and regulatory requirements in various countries to provide reference for the development of such products.