Therapeutic Goods Administration (TGA) makes final ruling on over-the-counter low-dose CBD, firing the starting gun for companies in race to bring products to market, increasing dose to up to 150 mg/day with efficacy still remaining as the biggest hurdle.
December 15th 2020
FreshLeaf Analytics has again welcomed the final decision today by the Therapeutic Goods Administration (TGA) to make registered low-dose CBD products available for sale in Australian pharmacies as a Schedule 3 drug. There was a significant change to the interim decision with an increase in dose up to 150mg/ day. The implementation date has also been brought forward to February 2021. The door is now open for companies to apply for registration of their applicable products to be available over the counter (OTC), although products are unlikely to hit shelves until later in 2021/ 2022.
DOSE AND DELIVERY
The final decision will allow the sale of registered pure CBD products (with 2% or less other cannabinoids, but only <1% THC) to adults in packets containing up to 4,500mg of CBD, amounting to 30 days supply of the recommended maximum daily dose of 150mg.
The announcement today reiterated that product delivery mechanisms are limited to oral, oral mucosal and sublingual formulations only, ruling out vaping or topical cream products. There was also an additional requirement that products be packaged securely.
THE RACE IS ON!
In creating a pathway for low-dose CBD products to become available over-the-counter, the TGA is opening the door for medicinal cannabis product companies to compete to bring registered low-dose CBD products to market.
The vast majority of products currently available through S4 unapproved pathways meet the criteria for S3 low-dose CBD.
ON THE SHELVES – NOT SO FAST!
The path to market, however, will not be straightforward. In order to register a product, a company must demonstrate that their products are high quality, safe, and efficacious. Proving safety and collating data on quality can be time consuming, and demonstrating efficacy to support registration, even at the proposed dose (of <150mg/day) could still be difficult for product companies. So while products could technically become available to consumers from February 2021, we may not see them on shelves until 2022.
- FreshLeaf supports final decision to make low-dose S3/OTC CBD products available in Australia as a Schedule 3 medicine but acknowledges that proving efficacy may still be a challenge not all companies are prepared to undertake
- Timeline for consumers seeing medication on shelves likely pushed to late 2021/2022
- Up to 150 mg/ day, 30 day supply to be available over the counter, products expected in late 2021/early 2022
- Oral, oral mucosal and sublingual formulations only – no vaping or topicals
- The vast majority of products currently available through S4 unapproved pathways meet the criteria for S3 low-dose CBD
- Products must be packaged securely
- Potential for $200M+ market in Australia
- ARTG registration will be required – no SAS-B
- Use of illicit CBD products may decrease
- Advertising to the general public will still not be allowed for OTC products
View the TGA media release here.
Cassandra Hunt, Managing Director of FreshLeaf commented: “History suggests that the first movers among product companies will be the winners, with the first movers in the medicinal cannabis industry in Australia still dominating the industry today. The race is now on to get products in the market as quickly and cost effectively as possible, assuming companies are able to overcome the challenge of proving efficacy.
Dr Melissa Benson, Advisory Board member of Applied Cannabis Research added: “The current registration pathway for Schedule 3 requires efficacy data, which helps support further clinical research in the area of low dose CBD medicines. This may, however, be challenging to produce at a low dose. Nonetheless, if fewer consumers seek out illicit CBD products which have unknown content/quality, then this move ultimately promotes greater safety for patients, which has to be the priority.”
Dr Mark Hardy, Medical Director and Addiction Specialist and CA Clinics said: “This could potentially result in more Australians benefiting from the therapeutic properties of cannabis. However, the effects of low-dose CBD may be negligible for many chronically ill patients. Pharmacists would also still need to consult with consumers to ensure they’re aware of potential drug-drug interactions, as CBD can affect the way certain other medications are metabolised. Bottomline, consumers should consult their GP before taking OTC products.”
Tony Whittaker, Regulatory Specialist FreshLeaf concluded: “I am excited that TGA has now provided a pathway to approval of over-the-counter CBD products – this gives a great opportunity for industry to develop products that consumers can access directly after consultation with their pharmacist. However, TGA has exacting standards, which will present a significant challenge to this young industry. We look forward to working with TGA to clarify the requirements for OTC CBD products and navigating the path to approval and commercialisation.”
Tim Drury, Director of Southern Cannabis Holdings: “Low-dose CBD has the potential to become a significant market in Australia for cannabis products. Companies wanting to compete in this space need to overcome substantial challenges – demonstrating safety, efficacy and quality of manufacturing – but the first to do so will be best positioned to succeed in a market that will, by our estimation, exceed $200 million per annum.”
FreshLeaf released its latest installment in its widely recognized Market Report series in Q3 2020.
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FreshLeaf Analytics, part of the Southern Cannabis Holdings group, is Australia’s leading source of data and information about the medicinal cannabis industry. FreshLeaf provides strategic consulting services to industry and government clients. For more information: [email protected] or [email protected] (+61) 2 8203 8741 @FreshLeafA
About Southern Cannabis Holdings: SCH specializes in building and operating cannabis businesses in markets where cannabis is regulated as a pharmaceutical product. SCH companies include CA Clinics, Applied Cannabis Research and FreshLeafAnalytics. To find out more about SCH, please visit www.southerncannabisholdings.com.au [email protected]