New Zealand’s medicine authority has issued its first licence to a Kiwi cannabis firm to manufacture medicines.
The GMP (Good Manufacturing Practice) licence will allow Helius Therapeutics to begin manufacturing medicines locally.
It marks a major milestone for New Zealand’s fledgling cannabis sector, which had a major surge in interest before the pandemic.
The GMP standards require manufacturers of pharmaceuticals to meet a number of stringent requirements that ensure safe and quality products.
An in-depth audit conducted by MedSafe confirms whether a firm meets the requirements. Everything from facility design, staff training, packaging, labelling, testing, storage and distribution processes are considered in the process.
It is understood that three other local firms hope to follow Helius down the GMP certification path.
Helius chief executive Carmen Doran said that this will give the doctors the confidence to prescribe Helius products to their patients.
It has been a long journey for Helius to get to this point, with the company first setting the objective when it launched in 2018.
“The GMP licencing process has been exhaustive, and rightly so,” Doran said.
“We’re making medicines, so there is no room for cutting corners.”
Helius pulled together an international team to work on successfully achieving compliance in the local market.
Doran was also familiar with the process, having worked at Novartis Pharmaceuticals for 10 years earlier in her career.
The cannabis sector has been relatively quiet over the Covid-19 era, but millions of dollars have already been poured into local businesses.
Helius has raised $48 million since its launch in 2018 – which has gone toward its 8800sq m indoor cannabis cultivation and manufacturing complex.
Bruce Wallace, the chief quality officer at the company, said this was essential in ensuring that Helius could consistently meet the high standards demanded by GMP certification.
“We’ve been pushing hard to build the facilities, procedures and systems that will ensure quality. 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.
However, this does not mark the end of the journey for Helius.
Although it now meets the requirements to manufacture medicines, the company will also have to demonstrate that to New Zealand’s Medicinal Cannabis Agency that the products produced meet the requisite quality standards.
“That’s not easy, but absolutely necessary to ensure products are safe and effective,” Wallace said.
“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.”
Helius is comparing a number of internationally manufactured medicines, and the company’s executives are confident they are on the right track.
However, there has been some criticism in the sector that the requirements set out for cannabis products are too stringent.
Doran said she is aware of these concerns, but noted this is no different from other areas of medicine.
“We totally get it,” Doran said.
“There’s no time to rest until New Zealand patients have more treatment options. However, 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.”
Doran anticipates that New Zealand patients will have access to their first Kiwi-made products from later this year.
“All of us at Helius Therapeutics, MedSafe, the Medicinal Cannabis Agency, and the wider industry are working incredibly hard to make that happen,” she said.
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