Another Kiwi medical cannabis company has achieved Good Manufacturing Practice (GMP) certification.
Following Helius Therapeutics in early August, Rua Bioscience also received GMP certification from Medsafe, New Zealand’s drug and medical device safety agency; operated by the country’s Ministry of Health.
Rua Biosciences emerged from Hikurangi Enterprises, the first company to be licensed to grow medicinal cannabis plants in New Zealand.
The GMP tick will allow Rua Bioscience to begin manufacturing its first medical cannabis product, which will be a cannabidiol (CBD) oil formulation. But more hurdles still lie ahead – for example, the company now has to file an application for a new medical cannabis product with the Medicinal Cannabis Agency in order to ship to the local market.
Nevertheless, the GMP status is an important milestone and will be of great help to the company’s other goal of exporting dried flowers to its German distributor, Nimbus Health.
“Being certified just 12 months after our facilities went live and accepted into the NZX is a tremendous achievement and testament to the great work that is being done here in Tairāwhiti by a very experienced, talented and persistent team,” said Rob Mitchell. , CEO of Rua Bioscience.
When Rua can deliver products for the domestic market, it assumes that this will be the case in early 2022.
Right now there is some unrest in the New Zealand sector over the slow approval process for imported and locally produced medical cannabis. The New Zealand health minister has apparently recently let loose in the industry, commenting on problems related to the supply and cost of pharmaceuticals after the expiry of the transitional rules for imported products because the industry “didn’t get out of the ass”.
As of October 1st, all medical cannabis products imported into or manufactured in New Zealand must be checked for minimum quality standards – and those standards are very high. You can read more about the situation here.
No products are reportedly ready, but 20 are awaiting approval.
It is a difficult time for New Zealand’s fledgling medical cannabis industry – and sadly for the patients too, who with some rush will not be able to get or afford the drugs they need while the shops and governorate are sorted.