Chinese Journal of Integrative Medicine

, Volume 20, Issue 12, pp 883–893 | Cite as

Review of the regulations for clinical research in herbal medicines in USA

  • Tony Yuqi TangEmail author
  • Fang-zhou Li (李方舟)
  • Janyne Afseth
Feature Article


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 2004. The 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 area. Key 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 trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In 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 considering in a herbal medicine clinical trial.


herbal medicine Chinese medicine clinical trial traditional medicine complementary medicine review 


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Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine and Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Tony Yuqi Tang
    • 1
    Email author
  • Fang-zhou Li (李方舟)
    • 2
  • Janyne Afseth
    • 3
  1. 1.Herose Clinical CentreSingaporeSingapore
  2. 2.Department of Law, School of HumanitiesInner Mongolia University of TechnologyHohhotChina
  3. 3.School of Nursing, Midwifery & Social Care, Faculty of Health, Life & Social SciencesEdinburgh Napier University, Sighthill Campus, Sighthill CourtEdinburghUK

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