TGA Medical Cannabis Approvals Update

Figures from Australia’s Therapeutic Goods Administration indicate the agency is being kept busy with SAS Category B approvals for medicinal cannabis.

Australia’s Special Access Scheme (SAS) enables access to therapeutic goods such as medicinal cannabis not included in the Australian Register of Therapeutic Goods (ARTG). These are considered “unapproved” therapeutic goods.

Only two medical cannabis products are listed on the ARTG at this point in time, Sativex (nabiximols) for treating certain patients with multiple sclerosis and Epidyolex (cannabidiol), for use in certain epileptic conditions. Medicines on the ARTG have been evaluated to ensure they meet strict standards of safety, quality and efficacy.

Medical cannabis approvals under the SAS usually fall into category B of the scheme; an application pathway accessible by health practitioners. Since 1992 and up to the end of March this year,  the TGA has approved more than 230,000 SAS Category B applications for unapproved medicinal cannabis products. More than half of those approvals have occurred in the last year.

Looking back over the last 12 months, here’s how the numbers stack up:

  • April 2021: 6682
  • May 2021: 9965
  • June 2021: 10,415
  • July 2021: 10,755
  • August 2021: 10,791
  • September 2021: 13,666
  • October 2021: 12,265
  • November 2021: 12,508
  • December 2021: 11,339
  • January 2022: 8,783
  • February 2022: 9,404
  • March 2022: 11,570

The figure for March this year translates to around 373 approvals a day.

Of the total number of applications ever approved, the most common indication has been for chronic pain (around 50%), followed by anxiety and cancer pain. The most prevalent age group approvals have been granted for is the 18-44 age bracket, which represents around half of all approvals.

In addition to the ~230,000 SAS Category B approvals, the TGA notes Australian patients may also be accessing unapproved medicinal cannabis products outside the SAS utilising the Authorised Prescriber scheme. As at the end of March 2022, there were 903 Authorised Prescribers in Australia. There is also another TGA pathway that may be used for medical cannabis – where a patient is facing premature death.

Further information about on the role of the TGA in relation to medicinal cannabis in Australia can be found here.

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