Rua Bioscience (NZX:RUA), New Zealand’s first Māori founded NZX-listed company, has received Good Manufacturing Practice (GMP) certification from Medsafe, enabling the company to start the manufacture its first medicinal cannabis product, a cannabinoid (CBD) oil.
GMP certification is the global standard for all pharmaceuticals and certifies that Rua can manufacture a product that is consistently safe and of acceptable quality. GMP is a pre-requisite for both domestic and export sales.
Rua Bioscience CEO, Rob Mitchell, says it is a significant milestone for the Tairāwhiti-based pharmaceutical 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 Tairāwhiti by a highly-experienced, talented and tenacious team,” he says.
“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. Rua Bioscience has a New Zealand exclusive contract for supply to 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,” he says.
Image credit: Rua Bioscience
Rua’s certification comes after a series of challenging external delays. 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.
Image credit: Rua Bioscience
Since the implementation of the Medicinal Cannabis Scheme, Rua has focused on meeting the heightened global demand for medicinal cannabis products through the establishment of world class cultivation and manufacturing capabilities in Tairawhiti.
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 per cent annually. The number of packs supplied in New Zealand in the year to 30 June 2021 was over 31,000; compared to just 2,000 in 2018. This growth is in spite of patients’ ability to access medicinal cannabis being constrained by a lack of available products, limited prescriber understanding of the clinical benefits of medicinal cannabis and the absence of government subsidies. 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.
Meanwhile the German market remains the largest single market for GMP (pharmaceutical) grade cannabis globally. German clinicians can prescribe medicinal cannabis for a variety of conditions and a great number of these prescriptions are paid for (reimbursed) by Statutory Health Insurers. In the year ending 30 June 2021, 313,500 prescriptions for medicinal cannabis products were reimbursed for German patients, valued at NZ$298m (€177m). These reimbursed sales are complemented by a substantial private-paying market that has an estimated additional value of NZ$169m (€100m).
"Achieving GMP certification is the penultimate step towards achieving Rua Bioscience's vision of delivering medicines to patients. We couldn't be more excited to be delivering on that vision" said Mr Mitchell.