Spain takes a significant step toward regulating cannabis as a pharmaceutical product.

Spain’s Royal Decree on Medicinal Cannabis has now come into effect, a long-awaited and significant move that finally brings cannabis medicines under strict drug control within the national healthcare system. This marks a decisive shift from political debate to evidence-based medicine, where standardized extract formulations, clinical oversight, and patient safety are central. This new regulatory framework in Spain signifies a landmark step in recognizing cannabis extracts as a legal therapeutic medicine, regulated with the same stringency as any other medicine. The implementation of this decree is a significant milestone not only for Spanish patients but also for the entire European Union, as it sets a highly credible standard for the future of cannabinoid therapy. Spain’s approach contrasts sharply with regulatory struggles in other major European markets. While countries like the UK, Germany, and Australia have seen their legal cannabis strategies encounter new regulations to address rapid developments, Spain is starting with strict drug control. The opportunities Spain offers are significant not only for Spain but also for Europe. If implemented properly, the decree will provide a transparent and compliant pathway for EU GMP-certified manufacturers, establish real-world clinical data, and set the tone for the next steps in the regulation of cannabinoid therapy across the EU.

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