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

Dwivedi S.; Vargas J.; Lal S. · Current reviews in clinical and experimental pharmacology · 2026

**Background & Methods** This is a comprehensive review examining current regulatory frameworks for cannabinoids and cannabis-based medicinal products across major global jurisdictions. The authors conducted a targeted literature search in PubMed and Google Scholar for English-language publications addressing the evolution of medical cannabis policies and national regulatory frameworks, with qualitative analysis of identified literature to evaluate relationships between international policy developments and national medical cannabis regulations. **Key Findings** • Three primary regulatory models were identified: traditional pharmaceutical approval pathways requiring robust clinical evidence; alternative access mechanisms such as compassionate-use and special access programs; and systems with varying levels of regulatory oversight, quality control, and patient protections, particularly for vulnerable populations. • Significant regulatory fragmentation exists globally, with considerable differences in regulatory requirements across countries creating substantial barriers to clinical research, limiting patient access, and hindering effective public health surveillance of cannabinoid therapies. • Critical challenges persist regarding product quality, standardization, labeling accuracy, and pharmacovigilance—particularly for botanical cannabis products where regulatory expectations often diverge from conventional pharmaceutical standards—necessitating stronger international harmonization and evidence-based monitoring systems. **Dosage & Administration** Not reported. **Safety & Adverse Effects** Not reported. The review addresses safety and product quality concerns as regulatory challenges rather than documenting specific adverse effects or safety data. **Evidence Quality** This is a narrative review article without original data analysis or systematic methodology, representing the lowest tier of evidence hierarchy (Level 5). Key limitations include: (1) reliance on qualitative rather than quantitative analysis; (2) potential for selection bias in literature identification; (3) inability to assess the methodological quality of included sources; (4) lack of meta-analysis or systematic comparison across regulatory frameworks; and (5) focus on policy documentation rather than clinical outcomes. The review synthesizes existing knowledge on regulatory approaches but cannot establish causal relationships or definitive efficacy claims. However, it effectively identifies gaps in international regulatory harmonization and highlights practical barriers affecting cannabinoid research and clinical implementation, providing valuable insights for policy development and future standardization efforts.

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