Australian medicinal cannabis companies have praised the Therapeutic Goods Administration (TGA) for its decision yesterday to not only allow cannabidiol (CBD) sales without a prescription at pharmacies, but with a higher cap on daily dosage limits and an earlier roll-out date.
The TGA made its final decision to down-schedule certain low dose cannabidiol (CBD) to Schedule 3, which refers to pharmacist-only medicine rather than its previous status as prescription-only.
After a safety review showed known adverse effects from CBD were not serious at low doses, a TGA senior medical officer determined the maximum daily dose could be lifted from 60mg/day to 150mg/day.
However, the breakthrough does not mean patients can simply buy medicinal CBD right away. The latest decision will come into effect on 1 February 2021 instead of the previous date of 1 June 2021, but products still need to be approved as meeting Schedule 3 criteria on the TGA's Australian Register of Therapeutic Goods (ARTG).
The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures.
Althea Group (ASX: AGH) is one of many Australian cannabis companies that will seek to get its formulations on the register, and is confident its robust drug master files for medications such as Althea CBD100 will meet the regulator's requirements.
"We applaud the TGA's final decision in this matter and are glad to see the administration listened to industry following the interim decision, and subsequently decided to increase the maximum recommended daily dose acknowledging that this dose is consistent with the expected safety profile of a Schedule 3 medicine," says Althea CEO and founder Josh Fegan.
"This decision provides confirmation of that marketplace and the company can now proceed with its plans to have over the counter Althea products available for Australian patients in 2021."
ECS Botanics (ASX: ECS) managing director Alex Keach was not expecting such a significant increase in the daily dosage.
"This is a surprise and great decision for the Australian cannabis industry and companies like ECS with a CBD focus," says Keach, whose company has been granted both a Medicinal Cannabis Manufacturing License and a Medicinal Cannabis Cultivation License from the Office of Drug Control (ODC) for its Tasmanian site.
"This final decision allows 2.5 times the daily dose than the interim decision, and is a huge vote for safety of CBD. This major increase in allowable daily dose will significantly increase awareness and demand for CBD in Australia."
Bod Australia described the TGA's decision as a landmark ruling that considerably broadens its addressable market.
The company has established a medical advisory board to make the most of the decision by developing product approval pathways.
"The TGA's decision to reschedule CBD products to over the counter medicines marks a major step forward for the sale of CBD in Australia and we are very confident that the establishment of our medical advisory board leaves the Company very well placed to capitalise," says Bod Australia CEO Jo Patterson.
"Bod is currently exploring a number of opportunities to launch CBD products under both its medicinal cannabis division, as well as its consumer focused CBD and hemp product vertical."
Professor Iain McGregor PhD, academic director Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney, is among the esteemed members of the new board.
Professor McGregor adds that he is looking forward to backing Bod and the wider commercial cannabis industry in its endeavour to create new and accessible medicine.
"As medicinal cannabis and CBD become increasingly accepted in Australia, it is great to see companies like Bod that are dedicated to developing evidence-based cannabinoid therapeutics. I am looking forward to supporting them in this endeavour," he says.
Cann Global (ASX: CGB), which has an import permit for two CBD hard pill products through its joint venture with Canada's Canntab, is working with a regulatory consultant to prepare its application to register both products on the ARTG in the coming months.
"These significant milestones whereby the United Nations have reclassified cannabis for medicinal use globally, and now the rescheduling of cannabidiol products in Australia show solid progress for the industry, and are testament to the positive recognition of the medicinal benefits of cannabis supported by extensive research," says Cann Global managing director Sholom Feldman.
"The team at Cann Global are looking forward to maximising the benefits of these regulatory changes for the Australian consumer who need improved access to these unique therapeutical products, and as a result creating significant increased shareholder value."
THC Global (ASX: THC) is another company in discussions with different parties to progress an ARTG registration of a new low-dose CBD medicine, and believes the increased daily dosage will lead to better patient outcomes.
This is a sentiment also shared by Little Green Pharma (ASX: LGP), which commends the decision as "nuanced and careful" for lifting the maximum daily dosage limit.
LGP explains the previous interim decision had provoked concerns low doses might make it harder to generate the rigorous efficacy data that is needed for getting backing on the TGA's schedule.
"ARTG registration requires sponsors to undertake time-consuming and expensive clinical trials and product registration activities to demonstrate the medicine's safety, quality and efficacy for the relevant registered indication, and with this revised decision it is anticipated sponsors will be far more confident progressing ARTG registrations at this higher dosing level," says LGP.
"LGP anticipates the decision will drive registration applications across a range of eligible CBD conditions and will serve to only further increase the accessibility and affordability of medicinal cannabis for Australian prescribers and patients."Never miss a news update, subscribe here. Follow us on Facebook, LinkedIn, Instagram and Twitter.
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