Research on Differences in Traditional Chinese Medicine Regulatory Legal Regimes within China’s Dual Legal Regions and Compliance Strategies for Cross-Jurisdictional Circulation

DOI: https://doi.org/10.62517/jel.202614320

Author(s)

Sinwan Li

Affiliation(s)

Beijing Tong Ren Tang Chinese Medicine Co.,LTD, China

Abstract

Against the backdrop of the Greater Bay Area and global industrial layout, disparate legal norms governing traditional Chinese medicine apply across China’s separate legal jurisdictions. Such institutional divergences create tangible obstacles to the international circulation of TCM products. This study systematically analyzes the TCM governance legal frameworks covering legislative standards, market access, quality supervision and distribution regulation, identifies the root causes of institutional discrepancies between domestic legal zones, and sorts out compliance risks and institutional frictions emerging in inter-jurisdictional TCM trade and exchange. Drawing on existing policy practices represented by the Announcement of the Guangdong Provincial Drug Administration on Simplifying Registration and Approval Processes for Marketed Proprietary Chinese Medicines from the Special Administrative Regions, this paper explores targeted compliance pathways for inter-jurisdictional TCM circulation that adapt to varied local legal regimes and industrial development demands. It further puts forward legal references to deepen cross-jurisdictional regulatory collaboration, advance coordinated high-quality development of the TCM industry within the Greater Bay Area, and facilitate the standardized global development of traditional Chinese medicine.

Keywords

Traditional Chinese Medicine Regulation; Legal Framework; Cross-Border Compliance

References

[1] Yu Hewei, Sun Yao. The Challenges and Solutions to Cross-Border Bankruptcy Assistance Mechanisms Between Mainland China and Hong Kong: An Analysis Based on Typical Cases [J]. Journal of Zhengzhou University of Aeronautics and Astronautics (Social Sciences Edition), 2025,44(3):42-50+104. [2] Li Yanhong. Construction and improvement pathways of the legal framework for corporate data asset protection [J]. Legal System Review, 2025, (34):118-120. [3] Feng Yujun, Shen Hongyi. Advancing scientific, democratic, and law-based legislation to establish a legal framework for the Hainan Free Trade Port [J]. Minsheng, 2025, (6):46-49. [4] Chen Yijian, Wang Wen. A Study on the Judicial Determination of Incitement Crimes under Hong Kong's National Security Law [J]. Hong Kong and Macau Studies, 2025, (4):34-45+94. [5] Huang Lina. Construction of the Legal System for Protecting China's Overseas Interests [J]. Legal Review, 2025, (26):22-24.