New Zealand medicinal cannabis company Helius Therapeutics is now able to manufacture locally-made medicines for patients after receiving GMP (Good Manufacturing Practice) certification.
Headquartered in Auckland, Helius has an 8,800sqm facility incorporating indoor cultivation, analytics, research, manufacturing, logistics, management and bonded distribution. The company holds a Licence to Manufacture Medicines and a commercial Medicinal Cannabis Licence from New Zealand’s Medicinal Cannabis Agency, and is approved to grow more than forty cannabis cultivars.
Issued by MedSafe, this latest approval also meets European standards (EU-GMP), which offers future export possibilities for Helius.
But the journey isn’t over yet, even in its own country. Helius products will still need to meet quality standards set by the Medicinal Cannabis Agency – a final hurdle to clear.
“That’s not easy, but absolutely necessary to ensure products are safe and effective,” said Helius Chief Quality Officer, Bruce Wallace. “Helius Therapeutics views this as non-negotiable and in line with bringing other medicines to market. We are, after all, talking about medicines for people and their loved ones,”
Helius Therapeutics CEO Carmen Doran says New Zealand’s standards are “equivalent or higher than those overseas”.
Commenting on criticism that NZ’s medicinal cannabis regulations are too strict and the time for getting approvals for locally-made products has been too long, Ms. Doran says medicines typically take five to 10 years to develop and approve – and Helius is well ahead of that.
As for when locally-made products may be available to New Zealanders, Ms. Doran says the company believes patients will have access from later this year.
While locally-produced medicines may not be available; there appears to be no shortage of imported products, to the point the New Zealand Medical Cannabis Council claimed earlier this year the country’s government scheme for unregulated products was out of control.
Having raised $48m in capital since 2018, a lot of sweat, blood, tears and bucks have gone into getting Helius Therapeutics to this point.
As well as human health, Helius also has an interest in cannabis-based animal health products. It is a part owner of Hale Animal Health, which is working to create a range of CBD (cannabidiol) products for animals.
“The health benefits are potentially enormous and we are incredibly excited to be one of the first animal welfare companies in the world to be conducting clinical trials and registering a CBD medicine for pets,” says Hale.