Global Regulatory Frameworks for Cannabinoids and Cannabis-Based Medicinal Products: A Comprehensive Review of Contemporary Approaches and Challenges

Introduction: Over the last decade, the regulation of cannabinoids and cannabis-based medicinal products has undergone significant transformation, determined by growing evidence of their therapeutic value and increasing concerns about safety, misuse, and product diversion. The objective of this review was to examine current regulatory frameworks across major jurisdictions from a public health policy perspective, highlighting how different approaches seek to balance patient access with health protection. Methods: This review followed a targeted literature search in scientific databased (PubMed and Google Scholar) to identify publications in English language addressing the evolution of medical cannabis and cannabinoid policies, with particular emphasis on the regulatory frameworks in various countries. The identified literature was qualitatively analyzed to evaluate the relationship between international policy developments and the evolution of national medical cannabis regulations and research activities. Results: This review identified three primary regulatory models: traditional pharmaceutical approval pathways that require robust clinical evidence; alternative access mechanisms, e.g., compassionate- use and special access programs; and regulatory systems which have varying levels of regulatory oversight, quality control, and patient protections, especially the vulnerable population. Discussion: While there has been an increasing global acceptance of cannabinoid-based therapies, considerable differences in regulatory requirements remain across countries. Such a fragmentation creates barriers to clinical research on cannabinoids and cannabis products, obscures patient access, and limits effective public health surveillance. Additionally, challenges related to product quality, standardization, labeling accuracy, and pharmacovigilance are particularly obvious for botanical cannabis products, where regulatory expectations often differ from those applied to conventional medicines. At the same time, innovative regulatory developments are emerging. Conclusion: The review highlights that a greater international regulatory harmonization, stronger quality assurance frameworks, and evidence-based monitoring systems are required for cannabinoids and cannabis products. These aspects are crucial for protecting public health, supporting scientific research, and enabling the responsible integration of cannabinoid-based therapies into modern healthcare systems.