Industry Update: October 2020

Regulatory News

13 Oct 2020

TGA Stats Sept2020 Tile
Another record month for medicinal cannabis approvals

The Federal regulator of prescription medicines, the Therapeutic Goods Administration (TGA), sets another record month for Medicinal cannabis approvals.

The TGA has published its September figures for SAS category B approvals setting a new record of 6,206 patients approved to access medicinal cannabis. This marks yet another strong month showing continuous demand for medicinal cannabis products. As of the 30th of September 2020, the TGA has approved over 67,000 SAS category B Applications for unapproved medical cannabis products (TGA: SAS Category B approval statistics).

Please note: these numbers do not include patients accessing medicinal cannabis via clinical trials or via Authorised Prescribers (medical practitioners who are approved to prescribe medical cannabis without needing to wait for patient approval from the TGA). There are now 115 Authorised Prescribers in Australia (TGA: SAS Category B approval statistics).

Since 2016, the medicinal cannabis market is estimated to have grown three times year on year with 2020 closing with roughly 30,000 active patients (Freshleaf Analytics Q3 2020). Of these, 20% of the patients are taking a low-dose CBD product. With the TGA down scheduling CBD to a schedule 3 medication, the demand for these products will continue to rise. Heading into 2021 CBD products could likely move to over the counter medication. The industry has responded to these changes with the overall price of CBD products decreasing (Freshleaf Analytics Q3 2020).

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