Helius Therapeutics has been issued with a GMP (good manufacturing practice) licence by MedSafe to begin manufacturing locally made cannabis medicines for Kiwi patients.
Chief executive Carmen Doran said while the process to achieve GMP compliance has been exhaustive, the granting of the licence marks the company’s most significant milestone yet.
She said: “The GMP licence means Helius can now move forward to manufacturing high-quality, affordable, Kiwi-made medicinal cannabis products. New Zealand doctors will be able to confidently prescribe in the knowledge that Helius meets stringent quality standards.”
“We’re making medicines, so there is no room for cutting corners,” Doran added. “Helius pulled together an internationally experienced leadership team from both the pharmaceutical and medicinal cannabis industries to successfully achieve this level of compliance.”
Helius has raised NZ$48m in capital since 2018 and invested heavily in its 8,800sqm indoor cultivation and manufacturing complex.
Chief quality officer Bruce Wallace said the GMP licence covers everything from the facility design to staff training, with MedSafe approving the company’s manufacturing, packaging, labelling, testing, storage and distribution processes.
He added: “Ultimately, that is what GMP is about – controlling all the factors that could influence the quality of our processes, so we know that patients will get exactly what their doctor prescribed, every time.”
Wallace said products will also need to meet quality standards set by New Zealand’s Medicinal Cannabis Agency to ensure safety, stability and efficacy via the product registration process.
“The final step for us in being able to supply medicines is providing the Medicinal Cannabis Agency with data and evidence to demonstrate these products meet the required standards.
“That’s not easy, but absolutely necessary to ensure products are safe and effective. Helius 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.”
Doran acknowledged frustration in some quarters that New Zealand’s medicinal cannabis regulations are too strict and that it’s taking too long for locally made products to be approved.
However, she added: “No-one is dragging the chain here. Despite being a botanical product, it’s worth remembering that medicines typically take five to 10 years to develop and approve – and we are well ahead of that.
“We believe patients will have access to Kiwi-made products from later this year.”