Canadian Cannabis Producer MediPharm Labs Exports Oil to US to Be Used in Clinical Trial

MediPharm Labs, a Canadian cannabis producer, announced recently that they had exported a shipment of cannabis oil containing cannabidiol (CBD) and tetrahydrocannabinol (THC) to the US to be used in a clinical trial (1).

Shipping cannabis to the US isn’t uncommon for scientific usage. In a recent press release (2), MediPharm Labs unveiled that their cannabis oil export was not an ordinary shipment. It marked the first time that a cannabis product originating from a Canadian licensed producer was shipped for a Phase 2 US clinical trial.

In the press release, it mentioned that the Phase 2 trial was being funded by the US National Institutes of Health (NIH) in Bethesda, Maryland but did not specifically list who was in charge of conducting the clinical trial.

The export process relied on (1,2):

• Its Drug Establishment License and product stability data.
• The United States’ Innovative New Drug Approval.
• U.S. Drug Enforcement Administration import approval.

MediPharm Labs detailed that these requirements took time to be met and needed capital investments (2), “The complex process relied on MediPharm's GMP Drug Establishment License, product stability data, US FDA Innovative New Drug Approval, and US DEA narcotic import approval.Steps to meet these requirements were initiated five years ago and involved large capital investments, demonstrating a unique pharmaceutical capability and approach that distinguishes MediPharm from other cannabis companies.”

“This development is significant as the majority of cannabis operators in the US are operating under State specific regulations that prohibits them from manufacturing for FDA sanctioned research activities and DEA approved shipments under federal narcotic laws,” the release stated (2).

The Canadian cannabis producer is hoping to become a leader in the production and development of pharmaceutical cannabinoids. The business had to go through a five-day, in-person inspection by the US Food and Drug Administration (FDA) in November 2022, which was the first of its kind for a cannabis facility from Canada (1).

References

1. Lamers, M. Canadian Producer Medipharm Exports Cannabis Oil to US for Clinical Trial https://mjbizdaily.com/canadian-producer-medipharm-exports-cannabis-oil-to-us-for-clinical-trial/ (accessed Sep 1, 2023).
2. Corp., M. L. Medipharm Labs Makes First Delivery of Cannabis Clinical Trial Material to US Research Partner and Provides Update on US FDA Status https://www.prnewswire.com/news-releases/medipharm-labs-makes-first-delivery-of-cannabis-clinical-trial-material-to-us-research-partner-and-provides-update-on-us-fda-status-301889986.html (accessed Sep 1, 2023).