Regulatory Frameworks for Integrated Medicine Management in USA, Europe, Japan, and China
Abstract
Integrated Medicine Management (IMM) is an all-encompassing healthcare approach that merges conventional Western medicine with complementary and alternative therapies. The primary objective of IMM is to address the underlying causes of illnesses and promote overall health and wellness of patients. As the utilization of complementary and alternative therapies becomes increasingly prevalent, the need for regulatory frameworks to ensure the safe and effective integration of these therapies into conventional healthcare systems is growing rapidly. Regulatory framework of IMM varies between countries, considering the facts that each country has its own unique approach to manage the integration of complementary and alternative therapies. In this article, we aim to explore the regulatory frameworks for IMM in four major markets, i.e. the United States (US), European Union (EU), Japan, and China. In the US, IMM regulation is centralized among different Federal agencies, however states have varying degrees of oversight. The US Food and Drug Administration (FDA) is responsible for regulating dietary supplements and herbal products, while state medical boards oversee the practice of alternative medicine. Additionally, the National Center for Complementary and Integrative Health (NCCIH) provides research and education on complementary and alternative therapies. Conversely, the regulation of IMM is more centralized in EU, where the European Medicines Agency (EMA) oversees the approval of herbal and homeopathic medicines, and the European Commission provides guidelines for the use of complementary and alternative therapies in healthcare. In Japan, the regulation of IMM is tightly controlled by the Ministry of Health, Labour and Welfare (MHLW), which approves traditional herbal medicines and acupuncture needles, and mandates practitioners to be licensed. China recognizes traditional medicine alongside with Western medicine. The State Administration of Traditional Chinese Medicine (SATCM) oversees the regulation of traditional medicine and promotes its integration with Western medicine.
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2. Tangkiatkumjai M, Boardman H, Walker DM. Potential factors that influence usage of complementary and alternative medicine worldwide: a systematic review. BMC Complement Med Ther. 2020 Dec;20(1):1-5.
doi: 10.1186/s12906-020-03157-2.
3. World Health Organization. WHO global report on traditional and complementary medicine 2019. World Health Organization; 2019 May 16.
4. Kemppainen LM, Kemppainen TT, Reippainen JA, Salmenniemi S, Vuolanto P. Use of complementary and alternative medicine in Europe: Health-related and sociodemographic determinants. Scand J Public Health. 2018 Jun;46(4):448-55. doi: 10.1177/1403494817733869.
5. Milenkovic J. Complementary and alternative medicine in European countries-legislative framework. Tradit Med Res. 2020;5(3):125. doi: 10.12032/TMR20190718125.
6. Mukherjee PK. Quality control and evaluation of herbal drugs: Evaluating natural products and traditional medicine. Elsevier; 2019 May 30.
7. Stone J. An ethical framework for complementary and alternative therapists. Routledge; 2005 Jun 29.
8. Seamon MJ, Clauson KA. Ephedra: yesterday, DSHEA, and tomorrow-a ten year perspective on the Dietary Supplement Health and Education Act of 1994. J Herb Pharmacother. 2005 Jan 1;5(3):67-86.
9. Zildzic M. Where is the place of alternative, complementary and integrative medicine in a comprehensive approach to health?. Int J Biomed Healthc. 2022;10(1):67-9.
doi: 10.5455/ijbh.2022.10.67-69.
10. James CS. FDA's Homeopathic Risk-Based Enforcement: Compromised Consumer Protection or Stepped-up Scrutiny?. Syracuse L Rev. 2020;70:1115.
11. Qu L, Li X, Xiong Y, Wang Z, Zhou H, Fan TP. Opportunities and hurdles to European market access for multi-herbal traditional Chinese medicine products: An analysis of EU regulations for combination herbal medicinal products. Pharmacol Res. 2022 Dec 1; 186:106528. doi: 10.1016/j.phrs.2022.106528.
12. Bilia AR, do Céu Costa M. Medicinal plants and their preparations in the European market: Why has the harmonization failed? The cases of St. John's wort, valerian, ginkgo, ginseng, and green tea. Phytomedicine. 2021 Jan 1; 81:153421. doi: 10.1016/j.phymed.2020.153421.
13. Knoess W, Wiesner J. The globalization of traditional medicines: Perspectives related to the European Union regulatory environment. Engineering. 2019 Feb 1;5(1):22-31. doi: 10.1016/j.eng.2018.11.012.
14. Ng JY, Kishimoto V. Multiple sclerosis clinical practice guidelines provide few complementary and alternative medicine recommendations: a systematic review. Complement Ther Med. 2021 Jan 1; 56:102595.
doi: 10.1016/j.ctim.2020.102595.
15. Yoshino T, Kashio A, Terasawa Y, Komatsu Y, Nagano K, Asakura H, et al. The Integration of Traditional Medicine with Conventional Biomedicine: A Narrative Review of the Japanese Perspective. J Integr Complement Med. 2023 Jul 1;29(6-7):372-9. doi: 10.1089/jicm.2022.0643.
16. Islam MN. Professionalization of Chinese medicine practice in Canada: from medical pluralism to neo-orientalism. Soc Theory Health. 2023 Sep;21(3):228-46.
17. Hipgrave D, Mu Y. Health system in China. Health Serv Eval. 2019:779.
18. Thakkar S, Anklam E, Xu A, Ulberth F, Valverde A, Whitmore T, et al. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regul Toxicol Pharmacol. 2020 Jul 1; 114:104647. doi: 10.1016/j.yrtph.2020.104647.
19. Kemppainen LM, Kemppainen TT, Reippainen JA, Salmenniemi S, Vuolanto P. Use of complementary and alternative medicine in Europe: Health-related and sociodemographic determinants. Scand J Public Health. 2018 Jun;46(4):448-55. doi: 10.1177/1403494817733869.
20. Cloatre E. Regulating Alternative Healing in France, And the Problem of ‘Non-Medicine’. Med Law Rev. 2019 May 1;27(2):189-214. doi: 10.1093/medlaw/fwy024.
21. Faisal-Cury A, Rodrigues DM. Prevalence and associated factors with homeopathy use in Brazil: a population-based study. Cad Saude Publica. 2022 Sep 23;38.
22. Takashima K, Morrison M, Minari J. Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. Stem Cell Rep. 2021 Jun 8;16(6):1425-34. doi: 10.1016/j.stemcr.2021.04.017.
23. Teng L. Pharmacovigilance for herbal and traditional medicines in Japan. In: Pharmacovigilance for Herbal and Traditional Medicines: Advances, Challenges and International Perspectives. Cham: Springer International Publishing; 2022 Aug 12. p. 371-83.
24. Halioua-Haubold CL, Peyer JG, Smith JA, Arshad Z, Scholz M, Waldmann D, et al. Focus: Genome Editing: Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan. Yale J Biol Med. 2017 Dec;90(4):683.
25. Nakanishi A, Bando H. Development of Health Resort Casino System in Integrative Medicine. Integr Med. 2019 Jul 6;1:5.
26. Miller MC. Complementary and integrative medicine: origins and expanding horizons. Otolaryngol Clin North Am. 2022 Oct 1;55(5):891-8.
doi: 10.1016/j.otc.2022.06.015.
27. Qaseem A, Snow V, Owens DK, Shekelle P, Clinical Guidelines Committee of the American College of Physicians. The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods. Ann Intern Med. 2010 Aug 3;153(3):194-9.
doi: 10.7326/0003-4819-153-3-201008030-00008.
28. Jones D, Templet A, Sierpina V, Kreitzer MJ. Functional medicine: theory, education, and practice. Explore (NY). 2009 May 1;5(3):177-9.
doi: 10.1016/j.explore.2009.03.008.
29. Pachuta DM. Chinese medicine: The law of five elements. India Int Cent Q. 1991;18(2/3):41-68.
30. Fan TP, Deal G, Koo HL, Rees D, Sun H, Chen S, et al. Future development of global regulations of Chinese herbal products. J Ethnopharmacol. 2012 Apr 10;140(3):568-86. doi: 10.1016/j.jep.2012.02.029.
31. Yuan R, Lin Y. Traditional Chinese medicine: an approach to scientific proof and clinical validation. Pharmacol Ther. 2000 May 1;86(2):191-8.
doi: 10.1016/S0163-7258(00)00039-5.
32. James CS. FDA's Homeopathic Risk-Based Enforcement: Compromised Consumer Protection or Stepped-up Scrutiny?. Syracuse L Rev. 2020;70:1115.
33. Dwyer JT, Coates PM, Smith MJ. Dietary supplements: regulatory challenges and research resources. Nutrients. 2018 Jan 4;10(1):41. doi: 10.3390/nu10010041.
34. Maegawa H, Nakamura T, Saito K. Regulation of traditional herbal medicinal products in Japan. J Ethnopharmacol. 2014 Dec 2;158:511-5.
doi: 10.1016/j.jep.2014.07.012.
35. Liang Z, Hu H, Li J, Xu X, Xue M, Zhang Y, et al. Advancing the regulation of traditional and complementary medicine products: A Comparison of five regulatory systems on traditional medicines with a long history of use. Evid Based Complement Alternat Med. 2021 Oct 27; 2021:5833945. doi: 10.1155/2021/5833945.
36. Awortwe C, Aklillu E. Global health implications of complementary and alternative medicine use. Nat Rev Cardiol. 2018 Oct;15(10):654-5. doi: 10.1038/s41569-018-0070-6.
37. Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Rep. 2015 Feb 10;79:1-6.
38. Eardley S, Bishop FL, Prescott P, et al. A systematic literature review of complementary and alternative medicine prevalence in EU. Forsch Komplementmed. 2012 Dec;19(Suppl 2):18-28. doi: 10.1159/000343125.
39. Maddocks-Jennings W, Wilkinson JM, Shillington D. Novel regulatory frameworks in complementary and alternative medicine. Complement Ther Clin Pract. 2005 Nov 1;11(4):280-6. doi: 10.1016/j.ctcp.2005.05.001.
40. Harnett JE, Cao ZJ, Brock PR, et al. Traditional and complementary medicine in pediatric oncology: Impact on the pharmacokinetics of chemotherapy. Cancer Chemother Pharmacol. 2013 Dec;72(6):1215-28.
doi: 10.1007/s00280-013-2312-5.
41. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Rep. 2008 Dec 10; 12:1-23.
42. Linde K, Barrett B, Wölkart K, Bauer R, Melchart D. Echinacea for preventing and treating the common cold. Cochrane Database Syst Rev. 2006 Jan 25;(1).
doi: 10.1002/14651858.CD000530.pub3.
43. Huh HJ. History and perspectives on the regulation of traditional medicine in Korea. J Ethnopharmacol. 2012 Apr 10;140(3):536-40. doi: 10.1016/j.jep.2012.01.056.
44. Park HL, Lee HS, Shin BC, et al. Traditional medicine in China, Korea, and Japan: A brief introduction and comparison. Evid Based Complement Alternat Med. 2012 Apr 10; 2012:429103. doi: 10.1155/2012/429103.
45. Chen KW, Liu T, Zhang H, Wang S. The use of complementary and alternative medicine (CAM) in treating and managing chronic pain in primary care: A systematic review. BMC Complement Altern Med. 2015 Dec;15(1):1-8. doi: 10.1186/s12906-015-0731-4.
46. Zhao Z, Li JV, Wang B, Jin H, Sun L, Lin Z. The regulation and use of herbal medicine in the treatment of cardiovascular diseases: Evidence from China. Curr Pharm Des. 2017 Jul 1; 23(26):3851-66.
doi: 10.2174/1381612823666170615100241.
47. Zhang Q, Ye M, Guo T, et al. Traditional Chinese medicine in the treatment of cardiovascular diseases: Efficacy and mechanisms. Pharmacol Ther. 2020 May 1; 209:107-79. doi: 10.1016/j.pharmthera.2020.107475.
48. Wang J, Chen Y, Shen J, et al. Traditional Chinese medicine for chronic obstructive pulmonary disease: Evidence and mechanism. J Ethnopharmacol. 2014 Dec 2; 156:42-9.
doi: 10.1016/j.jep.2014.08.041.
49. Wang S, Duan Y, Wang J, et al. The regulatory landscape of traditional Chinese medicine and traditional herbal products: Perspectives from China and the European Union. Front Pharmacol. 2021 Feb 16; 11:625029.
doi: 10.3389/fphar.2020.625029.
50. Sato H. The development of traditional Chinese medicine in the 21st century: A perspective from modern pharmacology. J Ethnopharmacol. 2021 Jan 10; 263:113193. doi: 10.1016/j.jep.2020.113193.
51. Zhang AL, Xue CC, Fong HH, et al. Integration of herbal medicine into evidence-based clinical practice: Current status and issues. Clin Rev Allergy Immunol. 2012 Dec; 43(3):172-80. doi: 10.1007/s12016-012-8293-4.
52. Luo L, Jiang M, Kang D, et al. Traditional Chinese medicine for the treatment of coronavirus disease 2019 (COVID-19): Advances and perspectives. Chin Med. 2020 Dec;15(1):1-8. doi: 10.1186/s13020-020-00305-7.
53. Shang HC, Zhang JH, Yao C, et al. Chinese herbal medicine for COVID-19: Protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2020 Apr 10;99(15)
doi: 10.1097/MD.0000000000019406.
54. Zhao ZZ, Zhou H, Jiang ZH, et al. The regulatory and ethical challenges in the development of Chinese herbal medicine for COVID-19. Pharmacol Res. 2020 Dec; 160:105072. doi: 10.1016/j.phrs.2020.105072.
55. Smith PJ, McGetrick E, Brown CA, et al. The development and regulation of traditional herbal medicines in the United Kingdom. J Ethnopharmacol. 2020 Dec 2; 261:112594.
doi: 10.1016/j.jep.2020.112594.
56. Tai J, Cheung S, Chan E, Hasman D. In vitro culture studies of Salvia miltiorrhiza (Danshen) in the enhancement of secondary metabolite production. Int J Mol Sci. 2010 Jan 28;11(1):518-30. doi: 10.3390/ijms11010518.
57. Tang JL, Liu BY, Ma KW. Traditional Chinese medicine. Lancet. 2008 Nov 8;372(9654):1938-40.
doi: 10.1016/S0140-6736(08)61354-9.
58. The Institute of Traditional Medicine. Legislative Issues Regarding TCM: The European Union. The Institute of Traditional Medicine; 2021.
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