On April 26, Japan’s Ministry of Health, Labor, and Welfare’s special committee greenlit cannabidiol (CBD) as an Orphan Drug, marking the first-ever approval of a cannabis-derived antiepileptic drug in the country. Marketed abroad under the brand name Epidiolex, CBD has now set a historic precedent in Japan’s pharmaceutical landscape. This significant development was reported by NIKKEI.
Orphan drugs target conditions that affect a small patient population and lack established treatment protocols. With this designation, CBD will now receive expedited review from the Pharmaceuticals and Medical Devices Agency (PMDA), accelerating its path to market.
In Japan, strict regulations require extensive clinical trials, which are currently shaping the future of CBD medications. The amendments of Cannabis Control Law in 2023 has facilitated these developments, and post-approval, CBD is expected to be used medically, fulfilling significant demand from Japanese healthcare professionals.
