New Zealand medicinal cannabis company Rua Bioscience has received Good Manufacturing Practice (GMP) certification from Medsafe, moving the company closer to manufacturing its first CBD oil product.
CEO Rob Mitchell described the development as a significant milestone for the firm, which comes a year after it commissioned its facility and listed on the New Zealand stock exchange.
He said: “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.”
Manufacturing will take place at Rua’s purpose-built facility in Gisborne and the compound CBD oil is estimated to be available as a prescription-only medicine by early 2022.
Mitchell added: “Achieving GMP certification means many of the common processes that will be required for the production of dried cannabis flower have also been reviewed.
“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.”
The certification has been granted after a series of external delays with chief operations officer Paul Naske describing the process as “challenging at times”.
However, he added: “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.”
Data released by the Ministry of Health under the Official Information Act shows that the number of packs of medicinal cannabis prescribed and supplied in New Zealand is growing at an average rate of 250% annually, while the German market remains the largest for GMP-grade cannabis globally.
Helius Therapeutics was issued with a GMP licence in August.