Regulatory Frameworks for Integrated Medicine Management in USA, Europe, Japan, and China

  • Sanyam Gandhi Senior Regulatory Affairs Lead, Takeda Pharmaceutical, 500 Kendall St, Cambridge, MA, USA, 02142
  • Omvir Sigh Advance Academic Programs, Krieger School of Arts and Sciences, 1717 Massachusetts Ave, NW, Washington, DC, USA 20036
  • Akhilesh Tiwari Department of Pharmacy, Indira Gandhi National Tribal University, Amarkantak, M.P. 484887, India
  • Prafulla Apshingekar Medicines and Healthcare products Regulatory Agency, London, E14 4PU, United Kingdom
  • Sachin Jain Oriental College of Pharmacy & Research, Oriental University Indore 453555 MP India
  • Vikas Jain Mahakal Institute of Pharmaceutical Studies, Ujjain M.P. 456664, India
  • Pradeep Pal Mahakal Institute of Pharmaceutical Studies, Ujjain M.P. 456664, India
  • Amber Vyas University Institute of Pharmacy Pt Ravishankar Shukla University Raipur, C.G., India

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.

Keywords: European Medicines Agency (EMA), National Center for Complementary and Integrative Health (NCCIH), Ministry of Health, Labour and Welfare (MHLW), complementary and alternative medicine (CAM therapies), Integrated Medicine Management (IMM)

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How to Cite
Gandhi, S., O. Sigh, A. Tiwari, P. Apshingekar, S. Jain, V. Jain, P. Pal, and A. Vyas. “Regulatory Frameworks for Integrated Medicine Management in USA, Europe, Japan, and China”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 2, June 2024, pp. 37-45, doi:10.22270/ijdra.v12i2.672.