To date, the TGA has approved SAS applications including, but not limited to, the following indications:
- chemotherapy-induced nausea and vomiting
- refractory paediatric epilepsy
- palliative care indications
- cancer pain
- neuropathic pain
- spasticity from neurological conditions
- anorexia and wasting associated with chronic illness (such as cancer).
The above list is provided as an overview and does not guarantee TGA approval for applications specifying these indications. SAS Category B applications are individually considered by the TGA based on the information provided with the application. A number of applications for indications other than those listed above have also been approved. Health professionals wishing to obtain further information about how to make a SAS application for a medicinal cannabis product should refer below.
SAS Category B approval statistics
Up to 28 February 2021, the TGA has approved over 99,000 SAS Category B applications for unapproved medicinal cannabis products.
A breakdown of the number of SAS Category B approvals by month for the previous 12 months is also provided below:
| Month | Number of SAS Category B approvals |
|---|---|
| March 2020 | 3926 |
| April 2020 | 3378 |
| May 2020 | 4133 |
| June 2020 | 4630 |
| July 2020 | 5564 |
| August 2020 | 5270 |
| September 2020 | 6206 |
| October 2020 | 5972 |
| November 2020 | 6356 |
| December 2020 | 5630 |
| January 2021 | 6126 |
| February 2021 | 8057 |
Source: https://www.tga.gov.au/medicinal-cannabis-role-tga
Please note:
- These figures represent the number of SAS Category B approvals only.
- The total number of approvals is provided since 1992 when TGA received the first known medicinal cannabis SAS application. However, the large majority of approvals have occurred since 2016.
- These figures are correct at the time of publishing, however are subject to change in order to reflect updates due to subsequent application cancellations, withdrawals and amendments.
- Approval numbers do not equal the actual number of patients receiving these medicines under the SAS. This is due to the possibility of repeat applications for the same patient. It is also possible that an individual patient may be associated with separate approvals for multiple products. SAS applications contain de-identified information and it is not possible for the TGA to accurately calculate patient numbers.
- Approval under the SAS does not necessarily mean the patient has accessed or continues to access treatment. Following approval, the actual supply of medicinal cannabis is a matter for the medical practitioner and their patient.
