Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use.

Zuanji Liang,Yitao Wang,Dongning Yao,Junlei Li,Carolina Oi Lam Ung,Hao Hu,Nianping Feng

doi:10.1155/2021/5833945

Zuanji Liang, Yitao Wang + Show 5 more

Open Access

https://doi.org/10.1155/2021/5833945

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Abstract

Background An appropriate regulatory system to ensure and promote the quality, safety, and efficacy of the products of traditional medicine (TM) and complementary medicine (CM) is critical to not only public health but also economic growth. The regulatory approach and evaluation standards for TM/CM products featured with a long history of use are yet to be developed. This study aims to investigate and compare the existing regulatory approaches for TM/CM products with a long history of use. Method A mixed approach of documentary analysis involving official and legal documents from official websites, as well as a scoping review of scholarly work in scientific databases about regulatory systems of TM/CM products in China, Hong Kong, Taiwan, Japan, and Korea, was employed in this study and used for comparison. Results For registration purposes, all five regulatory systems recognized the history of use as part of the totality of evidence when evaluating the safety and efficacy of TM/CM products with a long history of use. Generally, the list of classic formulas is predefined and bound to the formulas recommended in the prescribed list of ancient medical textbooks. Expedited pathways are usually in place and scientific data of nonclinical and clinical studies may be exempted. At the same time, additional restrictions with the scope of products constitute a comprehensive approach in the regulation. Quality assurance and postmarketing safety surveillance were found to be the major focus across the regulatory schemes investigated in this study. Conclusion The regulatory systems investigated in this study allow less stringent registration requirements for TM/CM products featured with a long history of use, assuming safety and efficacy to be plausible based on historic use. Considering the safety and efficacy of these products, regulatory standards should emphasize the technical requirements for quality control and postmarket surveillance.

Highlights

Traditional medicine (TM) and complementary medicine (CM) refer to a group of healthcare practices approaches that may be integrated into the mainstream healthcare system to various extent depending on the theories, beliefs, experiences, and culture indigenous to the population [1]
Considering the regulatory need and the general quest for developing a reasonable regulatory system for traditional medicine (TM)/CM products with a long history of use, this study aims to investigate the existing regulatory approaches that adopt the concept of risk-based approach to TM/CM products with a long history of use and to illustrate a comparison. e study findings will help improve the understanding about the global regulatory landscape for TM/CM products and inform the formulation of technical requirements for the registration approval of TM/CM products
When traditional Chinese medicine (TCM) products listed in the well-established publications are to be applied for new indications or new administrating routes, data about clinical efficacy is required for further evaluation

Summary

Introduction

Traditional medicine (TM) and complementary medicine (CM) refer to a group of healthcare practices approaches that may be integrated into the mainstream healthcare system to various extent depending on the theories, beliefs, experiences, and culture indigenous to the population [1]. E regulatory approach and evaluation standards for TM/CM products featured with a long history of use are yet to be developed. Is study aims to investigate and compare the existing regulatory approaches for TM/CM products with a long history of use. All five regulatory systems recognized the history of use as part of the totality of evidence when evaluating the safety and efficacy of TM/CM products with a long history of use. E regulatory systems investigated in this study allow less stringent registration requirements for TM/CM products featured with a long history of use, assuming safety and efficacy to be plausible based on historic use. Considering the safety and efficacy of these products, regulatory standards should emphasize the technical requirements for quality control and postmarket surveillance

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