Liang Zuanji, Hu Hao, Li Junlei, Yao Dongning, Wang Yitao, Ung Carolina Oi Lam
Institute of Chinese Medical Sciences, State Key Laboratory of Quality Research in Chinese Medicine, University of Macau, Macao, China.
Evid Based Complement Alternat Med. 2021 Oct 27;2021:5833945. doi: 10.1155/2021/5833945. eCollection 2021.
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.
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.
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.
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.
建立一个适当的监管体系以确保和促进传统医学（TM）和补充医学（CM）产品的质量、安全性和有效性，这不仅对公众健康至关重要，对经济增长也很关键。针对使用历史悠久的TM/CM产品的监管方法和评估标准仍有待制定。本研究旨在调查和比较针对使用历史悠久的TM/CM产品的现有监管方法。
本研究采用了一种混合方法，包括对官方网站上的官方和法律文件进行文献分析，以及对中国、中国香港、中国台湾、日本和韩国科学数据库中关于TM/CM产品监管体系的学术著作进行范围综述，并用于比较。
出于注册目的，所有这五种监管体系在评估使用历史悠久的TM/CM产品的安全性和有效性时，都将使用历史视为全部证据的一部分。一般来说，经典配方清单是预先确定的，并与古代医学教科书规定清单中推荐的配方相关联。通常设有快速审批途径，非临床和临床研究的科学数据可能会被豁免。同时，对产品范围的额外限制构成了监管中的一种综合方法。质量保证和上市后安全监测是本研究调查的所有监管方案中的主要重点。
本研究中调查的监管体系对使用历史悠久的TM/CM产品的注册要求较为宽松，前提是基于历史使用情况，其安全性和有效性似乎是合理的。考虑到这些产品的安全性和有效性，监管标准应强调质量控制和上市后监测的技术要求。
