Are national quality standards for traditional Chinese herbal medicine sufficient? Current governmental regulations for traditional Chinese herbal medicine in certain Western countries and China as the Eastern origin country

Complementary Therapies in Medicine

Volumn 13, Issue 3, 2005, Pages 183-190

  Dobos, G J ^a   Tan, L ^a   Cohen, M H ^b   McIntyre, M ^c   Bauer, R ^d   Li, X ^e   Bensoussan, A ^f  

^a UNIVERSITY OF DUISBURG ESSEN   (Germany)

^b HARVARD MEDICAL SCHOOL   (United States)

^c Midsummer Clinic   (United Kingdom)

^d UNIVERSITY OF GRAZ   (Austria)

^e PEKING UNIVERSITY   (China)

^f UNIVERSITY OF WESTERN SYDNEY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ARISTOLOCHIC ACID; CHINESE DRUG; HERBACEOUS AGENT; NON PRESCRIPTION DRUG;

ARTICLE; AUSTRALIA; CERTIFICATION; CHINA; CHINESE MEDICINE; DRUG ACTIVITY; DRUG FORMULATION; DRUG POTENTIATION; DRUG QUALITY; DRUG SAFETY; GERMANY; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; HERBAL MEDICINE; HUMAN; LEGAL ASPECT; MEDICAL EDUCATION; RISK BENEFIT ANALYSIS; STANDARDIZATION; UNITED KINGDOM; UNITED STATES; WESTERN HEMISPHERE;

CONSUMER PRODUCT SAFETY; DEVELOPED COUNTRIES; DRUG AND NARCOTIC CONTROL; DRUGS, CHINESE HERBAL; HUMANS; QUALITY CONTROL;

EID: 24344445279     PISSN: 09652299     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ctim.2005.06.004     Document Type: Article

References (41)

1. I. Hosbach G. Neeb S. Hager S. Kirchhoff B. Kirschbaum In defence of traditional Chinese herbal medicine Anaesthesia 58 2003 280-300
2. C.A. McRae K. Agarwald D. Multimer M.F. Bassendine Hepatitis associated with Chinese herbs Eur J Gastroenterol Hepatol 14 5 2002 559-562
3. J.E. Ferguson R.J.G. Chalmers D.J. Rowlands Reversible dilitated cardiomyopathy following treatment of atopic eczema with Chinese herbal medicine Br J Dermatol 136 1997 592-593
4. J.L. Nortier M.C. Martinez H.H. Schmeiser V.M. Arlt C.A. Bieler M. Petein et al. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi) N Engl J Med 342 23 2000 1686-1692
5. D. Pach S.N. Willich C. Becker-Witt Availability of research results on traditional Chinese pharmacology Forsch Komplementärmed Klass Naturheilkund 9 2002 352-358
6. NBJ's annual industry overview VII (May-June 2002). Nutr Bus J.
7. The Medical Letter. Dietary Supplements Health Education Act 2002; 103 P.L. 417; 108 Stat. 4325; 1994.
8. Statement of John M. Taylor. Associate Commissioner for Regulatory Affairs. Food and Drug Administration, before the U.S. Senate Committee on Commerce 10/28/03, http://www.fda.gov/ola/2003/dietarysupplements1028.html, URL 02/2005.
9. M.H. Cohen Complementary and alternative medicine: Legal boundaries and regulatory perspectives 1998 Johns Hopkins University Press Baltimore
10. Website for the Acupuncture & Oriental Medicine Alliance, http://www.acuall.org, URL 02/2005.
11. D.M. Eisenberg M.H. Cohen A. Hrbek J. Grayzel M.I. van Rompay R.A. Cooper Credentialing complementary and alternative medical providers Ann Intern Med 137 2002 965-973
12. J. Barnes Quality, efficacy and safety of complementary medicines: fashions, facts and the future. Part I. Regulation and quality Br J Clin Pharmacol 55 2003 226-233
13. MHRA press release: Concern over quality and safety standards of traditional Chinese medicines (2001/0448), http://medicines.mhra.gov.uk/whatsnew/pressrelease/tcm.htm, URL 08/2004.
14. House of Lords' Select Committee on Science and Technology. Complementary and Alternative Medicine. The Stationery Office. Session 1999-2000; 6th Report.
15. L.A. Walker S. Budd UK: The current state of regulation of complementary and alternative medicine Complement Ther Med 10 1 2002 8-13
16. Department of Health: Government Response to the House of Lords' Select Committee on Science and Technology's Report on Complementary and Alternative Medicine. The Stationery Office 2001.
17. Institut für Demoskopie Allensbach. München, Germany; 2001.
18. Arzneimittelgesetz. Arneimittelgesetz BGBI. I Nr. 73, §§ 43-44. Germany.
19. Bayerische Landesanstalt für Bodenkultur und Pflanzenbau, 2004, http://www.stmlf.bayern.de, URL 08/2004.
20. Apothekenbetriebsordnung. Verordnung, über den Betrieb von Apotheken BGBI. I, § 6 Abs. 3. Germany; 1995.
21. Bauer R. Traditionelle Chinesische Medizin. Eschborn, Germany: Gori-Verlag; 2001.
22. F. Friedel Dokumentation von Erfahrungsmaterial der chinesischen Arzneitherapie Forsch Komplementärmed 2 1995 344-346
23. www.apo-ag.de, URL 02/2005.
24. J. Hummelsberger A. Wiebrecht Kirchhoff I. Hosbach K. Bervoets-Fauska R. Rapp Centrum für Therapiesicherheit in der Traditionellen Chinesischen Arzneitherapie (CTCA) gegründet Zeitschrift für TCM 3 2003 3-5
25. Wagner H, Bauer R, Peigen X, Jianming C, Jianghua L. Chinese drug monographs and analysis. In: Verlag für Ganzheitliche Medizin. Kötzting/Bayerischer Wald, Germany: Dr Erich Wühr GmbH; 1999.
26. H. Wagner R. Bauer Analytik von TCM-Drogen Dtsch Apoth Ztg 144 2004 5007-5011
27. Stöger E, Friedl F. Arzneibuch der chinesischen Medizin. In: Deutscher Apothekenverlag. Stuttgart, Germany; 2004.
28. U. Bomme Feldanbau chinesischer Heilpflanzen Z Phytother 172 2001
29. D. Melchart K. Linde W. Weidenhammer S. Hager D. Shaw R. Bauer Liver enzyme elevations in patients treated with traditional Chinese medicine J Am Med Assoc 282 1 1999 28-29
30. D. Melchart S. Hager J.Z. Liao W. Weidenhammer Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds Forsch Komplementarmed 5 3 1998 132-135
31. A.H. MacLennan D.H. Wilson A.W. Taylor The escalating cost and prevalence of alternative medicine Prev Med 35 2002 166-173
32. Bensoussan A, Myers SP. Towards a safer choice: The practice of traditional Chinese medicine in Australia. Campbelltown, NSW: Faculty of Health; University of Western Sydney Macarthur; 1996. ISBN/ISSN 187576044X.
33. D.R. Briggs The regulation of herbal medicines in Australia Toxicology 181-182 2002 565-570
34. Australian Government of Health and Ageing, Therapeutic Goods Administration. Draft "Australian Regulatory Guidelines for Complementary Medicines: Part I, Registration of Complementary Medicines, March 2004".
35. A.L. Carlton A. Bensoussan Regulation of complementary medicine practioners in Australia: Chinese medicine as a case example Complement Ther Med 10 1 2002 10-26
36. A. Bensoussan S.P. Myers A.K. Drew I.M. Whyte A.H. Dawson Development of a Chinese herbal medicine toxicology database J Toxicol Clin Toxicol 40 2 2002 159-167
37. Homepage of the State Administration of TCM People's Republic of China 2004. Chinese herbal medicine, http://www.satcm.gov.cn/english_satcm/zhongyao.htm, URL 02/2005.
38. Z.G. Wang J. Ren Current status and future direction of Chinese herbal medicine Trends Pharmacol Sci 23 8 2002 347-348
39. Y. Zhou T. Baker Traditional Chinese medicine in contemporary China Md Med 3 1 2002 13-15
40. K. Harmsworth G.T. Lewith Attitudes to traditional Chinese medicine amongst Western trained doctors in the People's Republic of China Soc Sci Med 52 1 2002 149-153
41. WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants. Geneva: WHO; 2003. ISBN 92-4-154627-1.