A harmonisation approach to traditional Chinese medicine registration in Asian countries

Abstract

The traditional Chinese medicine (TCM) industry is critical to not only for public health but also for economic growth. According to the European Union (EU) directives, under the EU framework for (traditional) herbal medicinal products, herbal medicines with long history of use can be registered in EU. However, there is a condition in this directive in which only those that have at least 10–15 years in the EU market are accepted for registration and/or marketing authorization. In author opinion, the condition of 10–15 years of use in EU countries set within the EU regulatory framework is with consideration of the genetic differences which can result in variation in adverse drug responses among different world populations. With this concept in mind, it is reasonable to project the principal of the EU directive to the Asian countries where TCM is originated. Countries like China, Singapore, Japan and South Korea that have well established drug registration framework are in best position in executing the best practice and facilitate harmonization of registration for TCM within the region. Furthermore, the registration process itself allows more safety and efficacy data to be collected systemically before and after product registration/marketing authorization. These are valuable information for future drug development. The therapeutic value of TCM is limitless, it has been left out in the EU regulatory framework, and the opportunity for it to be expanded and carried forward in modern medicines is shadowed by the limited number of TCM that are qualified to be registered under the EU regulatory framework. An early establishment of a harmonized risk-based registration process for TCM in Asian countries is important. This will strengthen the database to substantiate the history of safe use and further preserving and expanding the therapeutic values of TCM within and beyond the Asian region.