Comparison and Registration Pathway of Nutraceuticals in Canada, India, Australia, Japan and South Korea

Abstract

One of the areas of healthcare that is expanding the fastest is nutraceuticals, which are dietary products that offer health advantages beyond simple nourishment. Nonetheless, there is still fragmentation in the global regulation of these items, with many nations implementing unique frameworks for post-market surveillance, approval and classification. This article compares the regulatory pathways for nutraceuticals in Canada, India, Australia, Japan and South Korea, highlighting similarities, differences and unique country-specific requirements. The review identifies that while Canada and South Korea emphasize pre-market approval systems, Australia and Japan employ tiered approaches, allowing both lighter oversight (notification-based) and stricter evaluations (clinical trial-based). India, meanwhile, classifies nutraceuticals primarily under food law, with emphasis on safety and compliance. The findings reveal a lack of global harmonization, leading to challenges in international trade, product registration and consumer protection. Recommendations include strengthening scientific validation, fostering regulatory convergence and enhancing post-market surveillance.