Inside USP: Traditional Chinese Medicines and Western Regulatory Paradigms - Pharmaceutical Technology

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Inside USP: Traditional Chinese Medicines and Western Regulatory Paradigms
Traditional Chinese Medicine is widely used, but questions persist regarding its regulatory status.

Pharmaceutical Technology
Volume 33, Issue 7, pp. 64-66


The USP–ChP annual scientific meeting brought together several experts to discuss the expanding use of TCM and associated regulatory issues. Modern research is ongoing in China and Western research facilities regarding the mechanisms of TCM's pharmacological action. USP will continue to exercise its role in developing TCM singular botanical ingredients via the dietary supplements and active drug and excipient moieties model.

James C. Griffiths, PhD, is vice-president of food, dietary supplements, and excipient standards at the US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1709,


1. USP (Boston: Wells and Lilly, 1820).

2. FDA, Food Additive Petition Expedited Review—Guidance for Industry and Center for Food Safety and Applied Nutrition Staff (Rockville, MD, 1999), accessed Jan. 26, 2009.

3. FDA, Guidance for Industry: Frequently Asked Questions about GRAS (Rockville, MD, 2004), accessed Jan. 26, 2009.

4. FDA, Numerical Listing of GRAS Notices (Rockville, MD, 2008), accessed Jan. 26, 2009.

5. PL 103-417, Dietary Supplement Health and Education Act, 1994, accessed Jan. 26, 2009.

6. L. Bhattacharyya et al., "The Value of USP Public Standards for Therapeutic Products," Pharm. Res., 21, 1725–1731 (2004).

7. R.L. Williams et al., "Official USP Reference Standards: Metrology Concepts, Overview, and Scientific Issues and Opportunities," J. Pharm. Biomed. Anal., 40, 3–15 (2006).


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