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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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

Conclusion

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,

References

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), http://www.cfsan.fda.gov/~dms/opa-expe.html accessed Jan. 26, 2009.

3. FDA, Guidance for Industry: Frequently Asked Questions about GRAS (Rockville, MD, 2004), http://www.cfsan.fda.gov/~dms/grasguid.html accessed Jan. 26, 2009.

4. FDA, Numerical Listing of GRAS Notices (Rockville, MD, 2008), http://www.cfsan.fda.gov/~rdb/opa-gras.html accessed Jan. 26, 2009.

5. PL 103-417, Dietary Supplement Health and Education Act, 1994, http://www.fda.gov/opacom/laws/DSHEA.html 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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
9%
Provide treatment for patients globally.
9%
All of the above.
41%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here