Rua Bioscience gets green light to produce medicinal cannabis products

Rua Bioscience, New Zealand’s first Māori-listed NZX-listed company, has received Medsafe’s Good Manufacturing Practice certification, which enables it to manufacture medical cannabis products.

Rua Bioscience co-founder Manu Caddy inspects plants with senior breeder Brandon Veevers.
Photo: Delivered

The first product Rua Bio will make is a cannabinoid (CBD) oil. CBD oils are commonly prescribed for pain, epilepsy, and anxiety in New Zealand.

GMP certification is the global standard for all pharmaceuticals. It certifies that Rua can produce a safe and acceptable quality product. GMP is a requirement for both domestic and export sales.

Rua Bioscience CEO Rob Mitchell says this is a significant milestone for the Tairāwhiti-based company.

“Receiving certification 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,” he says.

“Simply put, GMP certification means we’ve come a long way in making products. The next step is to submit an application for a new medical cannabis product to the Medical Cannabis Agency for an evaluation based on the Minimum quality. ” Norms.

“Although it is unclear how long the application review process will take, we expect to be able to deliver products to the domestic market in early 2022.”

The product will be manufactured in the purpose-built facility in Gisborne and the compound CBD oil will be available in New Zealand as a prescription drug.

“Achieving GMP certification means that many of the common processes required for the production of dried cannabis flowers have also been reviewed.

“Rua Bioscience has an exclusive New Zealand contract for the supply of German pharmaceutical distributor Nimbus Health, so we can start executing these orders as soon as dried flower products have gone through similar approval processes.

“Earning GMP certification is the penultimate step in realizing Rua Bioscience’s vision of delivering medicines to patients. We are very excited to make that vision a reality,” said Mitchell.

Rua certification comes after a series of challenging external delays.

Chief Operations Officer Paul Naske sees the process as an invaluable learning opportunity that will help the company bring more products to market.

“Although the process was sometimes challenging, we were always convinced of our people, processes and a positive result.

“It’s important to remember that the New Zealand industry currently relies heavily on overseas laboratories for critical pieces of the GMP puzzle and will streamline industry practices,” says Naske.

Since implementing the Medicinal Cannabis Scheme, Rua has focused on meeting the increased global demand for medical cannabis products by building world-class cultivation and manufacturing capabilities in Tairawhiti.

Data released by the Department of Health under the Official Information Act shows that the number of packs of medical cannabis prescribed and delivered in New Zealand is growing at an average of 250 percent annually.

The number of packages shipped in New Zealand was over 31,000 in the year ended June 30, 2021, compared to just 2,000 in 2018.

This growth, despite the limited ability of patients to access medical cannabis, is constrained by a lack of available products, a limited understanding of prescribers about the clinical benefits of medical cannabis, and the lack of government subsidies.

Meanwhile, the German market remains the world’s largest single market for GMP quality (pharmaceuticals) cannabis.

German doctors can prescribe medical cannabis for a variety of diseases, and a large number of these prescriptions are paid for (reimbursed) by statutory health insurers.

In the year ended June 30, 2021, 313,500 prescriptions for medical cannabis products were reimbursed to German patients worth NZ $ 298 million (€ 177 million). These refunded sales are complemented by a sizable privately paid market with an estimated additional value of NZ $ 169 million (€ 100 million).

source https://www.bisayanews.com/2021/09/30/rua-bioscience-gets-green-light-to-produce-medicinal-cannabis-products/