Japan to allow marijuana-derived medicines as pharmaceuticals

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Japan to allow marijuana-derived medicines as pharmaceuticals

According to Bloomberg, a Japanese health ministry panel recommended that marijuana-derived medicines be treated the same as pharmaceuticals.

The expert panel, convened on Thursday, recommended a revision of the country's policy on drugs to allow the import, manufacture and use of medicines derived from cannabis.

The committee said in a report that a policy change would synchronize Japan with international standards while meeting the medical needs of the growing nation.

The amendment will include cannabis products that have already proved safe and efficient under provisions governing pharmaceuticals and medical devices, such as the Epidiolex, subject to clinical trials in Japan.

Epidiolex is the first FDA-approved CBD medicine for treating children with severe epilepsy. The medicine was approved for use in treating seizures related to Lennox-Gastaut syndrome and Dravet's syndrome. The FDA approved Epidiolex for managing seizures related to the tuberous sclerosis complex in July.

Britain's cannabinoid drug company GW Pharmaceuticals plc, acquired by Jazz Pharmaceuticals plc JAZZ last year, reported earlier on its positive Phase 3 clinical trial of Epidiolex oral solution in seizures related to tuberous sclerosis complex, which was published in JAMA Neurology.

The results showed that patients receiving Epidiolex as a treatment had significantly fewer TCS-associated seizures of 48.6% compared to placebo 26.5% This trial was the basis for the FDA approval of Epidiolex for TSC-related seizures in July 2020.

Jazz Pharmaceuticals began building a new state-of-the-art manufacturing facility at Kent Science Park KSP in Sittingbourne, UK in March, with an investment of over $100 million. The new facility is designed to support the company's two regulatory-approved cannabis-based medicines, such as Epidiolex, and to support future capacity for developing new drugs.

The country's health ministry held a meeting earlier this year to discuss the revision of the Cannabis Control Law from 1948 to streamline the legalization of cannabis for medical use. The provision to criminalize its consumption for recreational purposes was considered by lawmakers.