The path towards FDA approval: A challenging journey for Traditional Chinese Medicine

Lisha You; Kun Liang; Rui An; Xinhong Wang

doi:10.1016/j.phrs.2022.106314

The path towards FDA approval: A challenging journey for Traditional Chinese Medicine

Pharmacol Res. 2022 Aug:182:106314. doi: 10.1016/j.phrs.2022.106314. Epub 2022 Jun 16.

Authors

Lisha You¹, Kun Liang², Rui An², Xinhong Wang²

Affiliations

¹ School of Pharmacy, Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai, China. Electronic address: youlisha@126.com.
² School of Pharmacy, Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Zhangjiang Hi-Tech Park, Pudong New Area, Shanghai, China.

PMID: 35718244
DOI: 10.1016/j.phrs.2022.106314

Abstract

In this review, the global contribution of tradition Chinese medicine will be debriefed. The underlying obstacles and limitations for TCM development and modernization will be summarized and analyzed accordingly. Statistics data and corresponding reasons will be presented to illustrate the very laborious progression of TCM globalization. Several innovative strategies and advanced technologies will be advised in the review in the hope of fully facilitating and accelerating TCM's expansion into the global markets.

Keywords: Chinese Traditional Patent Medicine; Clinical trial; FDA; Globalization; Modernization; Traditional Chinese Medicine (TCM).

Publication types

Letter
Review

MeSH terms

Drugs, Chinese Herbal* / therapeutic use
Internationality
Medicine, Chinese Traditional*

Substances

Drugs, Chinese Herbal