Review of the Regulations for Clinical Research in Herbal Medicines in USA

作     者：Tony Yuqi Tang 李方舟 Janyne Afseth 

作者机构：Herose Clinical Centre190 Clemenceau Ave#03-24SSCSingapore 239924 Department of LawSchool of HumanitiesInner Mongolia University of Technology49 Aimin StreetHohhot 010051China School of NursingMidwifery & Social CareFaculty of HealthLife & Social SciencesEdinburgh Napier UniversitySighthill Campus Sighthill CourtEdinburgh EH114BNUK 

出 版 物：《Chinese Journal of Integrative Medicine》 (中国结合医学杂志（英文版）)

年 卷 期：2014年第20卷第12期

页      面：883-893页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 1006[医学-中西医结合] 1005[医学-中医学] 1002[医学-临床医学] 100602[医学-中西医结合临床] 10[医学] 

基　　金：Office of Alternative Medicine National Institutes of Health 

主　　题：herbal medicine Chinese medicine clinical trial traditional medicine complementary medicine review 

摘      要：In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June *** approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this *** words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical *** critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital *** consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.