GMP Certification Unlocks New Global Distribution and Clinical Research Opportunities
Tilray, a global leader in medical cannabis research and production, today announced that it has become the first medical cannabis producer in North America to be GMP certified in accordance with the European Medicines Agency’s (EMA) Good Manufacturing Practice (GMP) standards. As North America’s only GMP certified medical cannabis producer, Tilray is uniquely positioned to expand distribution of its pharmaceutical-grade medical cannabis products to patients, physicians, pharmacies, hospitals and researchers in new markets around the world.
“GMP certification is the most rigorous standard that manufacturers of medical products must meet in their production processes, and it provides regulators and health care providers in countries new to medical cannabis with certainty that Tilray products are the safe and smart choice,” said Dr. Joshua Eades, Tilray’s Chief Science Officer.
As an internationally recognized standard, GMP is designed to ensure that medicines are consistently produced and controlled with the highest levels of quality and purity. Tilray is currently the only medical cannabis producer in North America to have a certificate of GMP compliance published in the European Union’s GMP database (EudraGMDP Certificate No: SUKLS34175/2016). The certificate was issued following a rigorous inspection by the Czech Republic’s State Institute for Drug Control (SUKL).
GMP certification enables Tilray to expand distribution of its products, including whole flower, oils or capsules, to new markets around the world. In 2016, Tilray became the first company to legally export medical cannabis products from North America to Australia and the European Union. In 2017, the company plans to expand distribution of its products to additional countries, including Germany which recently legalised medical cannabis.
GMP certification also allows Tilray to continue to break new ground in clinical research, advancing the science, safety and efficacy of medical cannabis for patients with a diverse range of conditions. Tilray currently supplies pharmaceutical-grade medical cannabis products for three different clinical trials in partnership with world-leading hospitals and universities:
- The first trial is being conducted in partnership with the University of British Columbia to examine the safety and tolerability of medical cannabis for Canadian military veterans and other patients suffering from PTSD.
- The second trial is being conducted in partnership with the University of Sydney, Chris O’Brien Lifehouse and the New South Wales government to study the safety, tolerability and efficacy of cannabinoids for chemotherapy-induced nausea and vomiting.
- The third trial is examining safety and tolerability of cannabinoids in children with Dravet Syndrome (a severe form of treatment-resistant epilepsy) at Toronto’s Hospital for Sick Children.
Tilray plans to announce additional research partnerships in the coming year.
Tilray is a global leader in medical cannabis research and production dedicated to advancing the science, safety, and efficacy of medical cannabis. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, pharmacies and researchers in Australia, Canada, the European Union and the Americas.