美国食品和药物管理局中草药新药临床试验申请

Investigational new drug application of Chinese herbal medicine in U. S. and regulatory requirements of U. S. Food and Drug Administration

近年来,中草药和植物药的研发越来越受到制药工业的关注。各国的药物管理机构也在逐步完善中草药和植物药的审批要求。本文主要介绍了美国食品和药物管理局对于中草药的临床试验申请的相关问题。

Recent years, the awareness of development of Chinese herbal medicine and botanical drugs is increasing. Drug authorities of different countries keep updating regulatory requirements for Chinese herbal medicine and botanical drug. This article specifically introduces regulatory issues about investigational new drug application of Chinese herbal medicine from United States Food and Drug Administration perspective.