New Zealand’s largest licenced medicinal cannabis company, Helius Therapeutics, has been issued with the industry’s first GMP (Good Manufacturing Practice) certificate by MedSafe, allowing the company to begin manufacturing locally-made medicines for patients.
“This is our most significant milestone yet. GMP certification means Helius can now move forward to manufacture New Zealand patients with high-quality, affordable Kiwi-made medicinal cannabis products,” says Carmen Doran, Chief Executive of Helius Therapeutics.
Helius has also gained the country’s first Licence to Manufacture Medicines for medicinal cannabis, so New Zealand doctors will be able to confidently prescribe in the knowledge that Helius meets the most stringent quality standards, adds Ms Doran.
Based in Auckland’s East Tamaki, Helius began the rigorous and complex journey for GMP certification as a start-up in 2018. Through an international recognition scheme, MedSafe’s latest approval also meets European standards, known as EU-GMP, opening future export possibilities for the 100% Kiwi-owned company.
“The GMP certification process has been exhaustive, and rightly so. We’re making medicines, so there is no room for cutting corners. Helius pulled together an internationally- experienced leadership team from both the pharmaceutical and medicinal cannabis industries to successfully achieve this level of compliance,” she says.
Having raised $48m in capital since 2018, Helius has invested significantly in its 8,800sqm indoor cannabis cultivation and manufacturing complex. New Zealand’s largest purpose-built facilities are designed to achieve precision-controlled cannabis cultivation, extraction, purification, and product manufacturing.
“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,” says Bruce Wallace, Chief Quality Officer at Helius Therapeutics.
Mr Wallace says the GMP certification covers a wide scope from facility design to the training of people. MedSafe assessed and approved the company’s manufacturing, filling, packaging, testing, storage and distribution processes. Over time, the Licence to Manufacture Medicines will expand to include other product types and other parts of the value chain.
As a newly licenced company in a new industry, Helius can expect routine GMP audits to ensure its high standards are maintained. As it adds additional manufacturing capabilities to its licence, each new manufacturing process type will trigger a new audit.
Ms Doran says ongoing audits are positive. “Having experienced, professional inspectors, such as the Medsafe GMP team, challenging your systems can only improve your processes and outcomes”.
While Helius now has the necessary Licence to Manufacture Medicines, products will still need to meet quality standards set by New Zealand’s Medicinal Cannabis Agency to establish safety, stability, and efficacy.
“The final step for us in being able to supply medicines is providing the Agency with enough 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,” says Mr Wallace.
Ms Doran agrees that patients and doctors need the utmost confidence that medicinal cannabis products prescribed are of uncompromising quality and safety.
“The Helius team has reviewed regulations and requirements for medicinal cannabis products in several major export markets. We can confidently say New Zealand’s standards are equivalent or higher than those overseas, and that’s a good thing,” she says.
As a leader in New Zealand’s newest industry, Helius acknowledges recent commentary that the country’s medicinal cannabis regulations are too hard and it’s taking too long for locally-made products to be approved.
“We totally get it. 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".
“In fact, we believe patients will have access to 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 says.
Carmen Doran says Helius has built the team and facilities to get the job done, motivated by an unwavering commitment to improve patients’ quality of life.
“It has been a tremendous effort from our founders, investors, and team to turn a vision into what is now a fully-fledged medicines production company. Being New Zealand’s first medicinal cannabis business to gain GMP certification and a Licence to Manufacture is a huge win for Helius and we’re all incredibly proud,” she says.