New Zealand’s Greenfern Industries Limited (GFI) has its sights set on registering an over-the-counter cannabidiol product in Australia.
In December 2020, Australia’s Therapeutic Goods Administration (TGA) approved down-scheduling certain CBD preparations to Schedule 3, which kicked in on February 1 last year. This makes qualifying products Pharmacist Only medicines, available without a prescription.
More than a year on and there are still no S3 CBD products available from Australian pharmacies. The reason for this is the regulatory hurdles CBD companies must clear, including proving a candidate product is effective in treating or managing whatever condition or symptom it is targeting; and within the dosage limitations of less than 150mg of CBD per day.
Greenfern Industries says it is about to get started on drawing up clinical trial protocols for a low dose CBD product. It’s a race against time as a number of companies want their products to be first listed on the Australian Register of Therapeutic Goods (ARTG) for S3 CBD.
“Speed to market is important because the first products to hit the pharmacy-only market will take a considerable market share,” said GFI managing director Dan Casey.
GFI has teamed up with Cannvalate-owned iNGENū for this initiative, an Australian-based research organisation specialising in cannabinoid and psychedelic research.
Mr. Casey notes GFI’s novel investigational medical product, GFI-782B, has completed all CMC (chemistry, manufacturing and controls) and toxicology requirements required for drug registration and is ready to commence first-in-human clinical trials.
What isn’t mentioned in the announcement is what condition will be targeted by GFI-782B.
As well as the Australian market, GFI is looking at potential pathways for GFI-782B to be used in New Zealand; and no doubt the company will come up with a snappier name for both markets.
Founded in 2019, the Taranaki-based firm listed on the NZX main board in October 2021 after a couple of successful crowdfunding rounds and capital wholesale investment.
In May last year, Greenfern Industries announced it had been named New Zealand’s first Toitū carbonzero certified medicinal cannabis and industrial hemp company. This was helped along by GFI’s hydroelectric power station, which is situated alongside Greenfern’s research, indoor growing and processing facility.