CBD frustration: Aussie supplement firms thwarted by rules while pharma advances march on

Complementary Medicines Australia (CMA) CEO Carl Gibson was speaking to NutraIngredients-Asia​ after biopharma firm MGC Pharmaceuticals announced a series of major business milestones, chief among them the Therapeutic Goods Administration (TGA) green-lighting its CBD-based Alzheimer’s disease treatment for clinical trials.

The firm, known for its medical cannabis innovations, received formal approval from the Australian regulator to begin Phase IIb of its clinical trial on CogniCann, a pharmaceutical-grade, GMP-certified medicinal cannabis formulation.

The latest phase of the trial, to be conducted in collaboration with the University of Notre Dame in Western Australia, will test CogniCann’s effects on mild dementia and Alzheimer’s symptoms in patients aged 65 and older. It has also been approved by the Human Research Ethics Committee (HREC).

Domestic and foreign approval

Outside of Australia, MGC has also received approvals in the EU, including a permit from the Slovenian Ministry of Health allowing it to develop phytocannabinoids at its extraction facility (one of the first EU facilities to develop its own natural phytocannabinoids).

Additionally, MGC is now the first Australian medicinal cannabis firm to have received SME qualification feom the European Medicines Agency (EMA), the TGA and FDA’s European counterpart.

This in turn enables MGC to apply for drug evaluation, official advice, and registration of its cannabidiol (CBD) products.

Approved trials versus permitted sales

When it comes to CBD health supplements, however, the rules are far stricter.