Another Kiwi medical cannabis company has been awarded GMP (Good Manufacturing Practice) certification.
Following Helius Therapeutics’ announcement in August*, Rua Bioscience has also received GMP certification from Medsafe, the New Zealand Medicines and Medical Devices Safety Authority; which is run by the country’s Ministry of Health.
Rua Biosciences emerged from Hikurangi Enterprises, the first company to secure a license to cultivate medicinal cannabis plants in New Zealand.
The GMP tick will enable Rua Bioscience to kick off manufacturing of its first medicinal cannabis product, which will be a cannabidiol (CBD) oil formulation. But more hurdles await – for example, the company now needs to submit a New Medicinal Cannabis Product Application to the Medicinal Cannabis Agency in order to supply into the local market.
Still, the GMP status is a significant milestone and will be a big help towards the company’s other goal of exporting dried flower to its German distribution partner, Nimbus Health.
“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 Tairāwhiti by a highly-experienced, talented and tenacious team,” said Rua Bioscience CEO Rob Mitchell.
As for when Rua will be able to supply product for the domestic market, it’s anticipating this will occur by early 2022.
There’s quite a bit of turmoil within the NZ sector at the moment over the slow approvals process for both imported and locally produced medical cannabis. NZ’s Health Minister apparently recently unleashed on the industry, commenting issues concerning supply and cost of medicines after interim arrangements for imported products expired would be because the industry “didn’t get off their asses“.
Since October 1, all medicinal cannabis products to be imported into or manufactured in New Zealand must be verified as meeting minimum quality standards – and those standards are very high. You can read more on the situation here.
There are reportedly still no products ready, but 20 awaiting approval.
It’s a difficult time for New Zealand’s still fledgling medical cannabis industry – and unfortunately for patients too, with some frantic they won’t be able to secure or afford the medicines they need while business and the government end of town gets sorted.
*Update: Helius Therapeutics announced its GMP certification in August, but it was awarded in July.