‘A significant milestone’ for Tairawhiti-based Rua Bioscience
Tairawhiti-based Rua Bioscience has the go-ahead from Medsafe to manufacture its first medicinal cannabis product, a cannabinoid (CBD) oil.
The company received a Good Manufacturing Practice (GMP) certification, which is the global standard for all pharmaceuticals and certifies that Rua can manufacture a product that is consistently safe and of acceptable quality and is a prerequisite for domestic and export sales.
Rua Bioscience chief executive Rob Mitchell called it a significant milestone for the nation's first Maori-founded NZX-listed company.
“Gaining certification just 12 months after commissioning our facilities and listing on the NZX is a massive achievement and a testament to the great work being done here in Tairawhiti by a highly-experienced talented and tenacious team,” he said.
“Put simply, GMP certification means we've moved a long way down the path to being allowed to manufacture products. The next stage is to submit a New Medicinal Cannabis Product Application to the Medicinal Cannabis Agency, who will undertake an assessment against the Minimum Quality Standards.
“While it is unclear how long the application review process will take, we anticipate being able to supply product for the domestic market by early 2022.
“Manufacturing will take place at our purpose-built facility in Gisborne and the compounded CBD oil will be available in New Zealand as a prescription-only medicine.
“Achieving GMP certification means many of the common processes that will be required for the production of dried cannabis flower have also been reviewed, Mr Mitchell said. “Rua Bioscience has a New Zealand-exclusive contract for supply intended for German pharmaceutical distribution partner, Nimbus Health so we will be able to start fulfilling those orders as soon as dried flower products have been through similar approval processes.”
Rua's certification comes after a series of challenging external delays and chief operations officer Paul Naske views the process as an invaluable learning opportunity that will ultimately hold the company in good stead as further products are brought to market.
“While the process has been challenging at times, we were always confident in our people, processes and of a positive outcome.
“It's important to remember that, at this point, the New Zealand industry is heavily reliant on overseas laboratories for critical pieces of the GMP puzzle. But this is temporary. As the industry develops, so too will New Zealand-based ancillary services, which will streamline industry practice,” he says.
According to a study published in the British Journal of General Practice, CBD oils are commonly prescribed in New Zealand for pain, epilepsy and anxiety .
“Achieving GMP certification is the penultimate step towards achieving Rua Bioscience's vision of delivering medicines to patients,” Mr Mitchell said.
“We couldn't be more excited to be delivering on that vision.”