Enlightenment of EU Herbal Medicinal Products regulation on the registration of Traditional Chinese Medicines in the Guangdong-Hong Kong-Macao Greater Bay Area

Abstract

Objective

This study analyzes the European Union's (EU's) regulatory practices of Herbal Medicinal Products (HMPs), aiming to provide implications for Traditional Chinese Medicines (TCMs) registration process within the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).

Methods

This paper conducts a comparative analysis of the regulatory agencies, legal frameworks, registration classifications, market authorization procedures, and the number of applications and approvals for both HMPs in the EU and TCMs in the GBA, thereby identifying the distinctive regulatory features across these regions.

Results

Our study finds that the EU has established a scientific, efficient, and harmonized regulation system for HMPs, whereas the registration of TCMs in the GBA is characterized by complexity and jurisdictional disparities in requirements and procedures. Drawing on the EU's advanced regulatory practices, the study offers recommendations to enhance the mutual recognition and accessibility of TCMs within the GBA.

Conclusion

This study offers a comprehensive understanding of the EU's HMPs regulation and the GBA's TCMs registration, contributing to the synergistic development of TCMs in the GBA.