Regulatory frameworks and evidence requirements for traditional, complementary and integrative medicines

Traditional, complementary and integrative medicine plays an important role in global health-care systems. Despite its widespread use and recognition by more than 170 Member States of the World Health Organization, many disparities in regulation exist between countries. We conducted a comparative analysis of the regulatory frameworks governing traditional medicine products in six high- or middle-income countries or jurisdictions where traditional medicine is used extensively: Australia, Canada, China, Republic of Korea, United States of America and the European Union. We focused on marketing authorization pathways, approval standards and successful approvals. We found differences in regulatory approaches, with countries adopting either clinical study-based or traditional knowledge-based pathways which led to varying requirements for non-clinical and clinical evidence. While the European Union and the United States acknowledge historical human-use evidence, relatively rigorous clinical investigations are required. Australia and Canada consider historical human-use evidence in marketing authorization for products that do not require professional supervision. Recent regulatory reforms in countries such as China and the Republic of Korea aim to enhance regulatory supervision. Across all jurisdictions, fluctuations in the number of successful applications persisted amid evolving policy changes and regulatory requirements. To promote the worldwide use of traditional medicine products, a globally coordinated, tiered and risk-based international framework is needed to ensure the efficacy, quality and safety of traditional medicine products. This approach requires establishing stable (i.e. predictable and consistently implemented) regulatory systems, strengthening the evidence on traditional medicine products with both clinical and real-world data, and facilitating regulatory convergence through reciprocity and globally harmonized evaluation standards.