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Medicinal cannabis: Role of the TGA
The Therapeutic Goods Administration (TGA) is responsible for ensuring that the therapeutic goods available for supply in Australia are safe and fit for their intended purpose. The TGA administers the Therapeutic Goods Act 1989 (the Act), which establishes the regulatory framework for all medicines in Australia.
The Act provides a number of mechanisms to enable access to unapproved therapeutic goods, such as medicinal cannabis. These products can be accessed access through:
While there are additional legal requirements that must be met before medicinal cannabis products can be imported and supplied through these schemes, they do provide a pathway for access to these medicines to appropriate patients.
Medicinal cannabis and the SAS
The TGA has a responsibility to encourage the use of medicines that are included in the Australian Register of Therapeutic Goods (ARTG), as these products have been evaluated to ensure they meet strict standards of safety, quality and effectiveness.
For this reason, it is expected that medical practitioners (prescribers) will have considered clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved medicinal cannabis product under the SAS.
Where products in the ARTG are found to not be clinically suitable, the SAS provides a pathway for prescribers to access unapproved products for individual patients on a case-by-case basis. It is important to note that the TGA does not vouch for the quality, safety and effectiveness of unapproved products accessed through the SAS and the prescriber and patient (via informed consent) accept responsibility for any adverse consequences of the treatment.
It is the responsibility of the prescriber making the application to specify for which indication they are intending to use the unapproved medicinal cannabis product.
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 31 May 2021, the TGA has approved over 120,000 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|
- 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.
- Australian patients may also be accessing unapproved medicinal cannabis products outside the SAS via the Authorised Prescriber scheme or in a clinical trial and these will not be captured in the SAS figures provided above. As of 31 May 2021 there are 263 Authorised Prescribers.
- Currently there are two medicinal cannabis products included in the ARTG. Sativex (nabiximols) is used to treat certain patients with multiple sclerosis and Epidyolex (cannabidiol) is used for patients with certain epileptic conditions. The above statistics does not include the use of these products.
SAS online system
As of 30 July 2018 an online system was introduced to enable the lodgement of SAS applications and notifications through an online system. The TGA has been working in collaboration with the State and Territory Health Departments to streamline the application processes pertaining to the prescription of and subsequent access to unapproved medicinal cannabis products in Australia.
The SAS online system includes functionality that will now allow prescribers in certain States and Territories to submit an application to both the Commonwealth and the relevant State/Territory Health Department simultaneously. Prior to the introduction of this system, prescribers of unapproved medicinal cannabis products were required to complete and separately submit paper forms to the TGA and relevant State Health Department.
Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at: Special Access Scheme online system.
Quality standard measures
The TGA is responsible for governing regulatory standards for medicinal cannabis products in Australia. Quality controls are implemented through standards such as the Therapeutic Goods -(Standard for Medicinal Cannabis) (TGO 93) Order 2017. TGO 93 provides appropriate regulatory controls to ensure that the quality of the medicinal cannabis and ingredients used in the manufacture is of an acceptable standard and safe for it consumer. For more information please review the Conforming with the TGO93 web page.
Scheduling of medicines
The TGA also plays a vital role in the scheduling of medicines in Australia. The Schedules are published in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) and may be adopted by state and territory jurisdictions to take legal effect.
On 1 November 2016, amendments were made to the scheduling of medicinal cannabis products. This involved Schedule 9 (S9) Prohibited Substances being down regulated to Schedule 8 (S8) Controlled Drug for certain medicinal cannabis products. The scheduling changes remain a decision for individual states/territories to include in their legislation for medicinal cannabis.
Scheduling of medicinal cannabis products
Cannabis and tetrahydrocannabinol
Under certain circumstances, cannabis (including seeds, extracts, resins and the plant or any part of the plant) and tetrahydrocannabinol (when extracted from cannabis) when prepared or packed for human therapeutic use, are 'Controlled Drugs' under Schedule 8 (S8) of the Poisons Standard.
Access will need to be confirmed with the relevant State/Territory noting that laws differ between jurisdictions. For State and Territory contact information please see: Access to medicinal cannabis products: using access schemes.
Cannabidiol (CBD) is one of the cannabinoids which may be extracted as a therapeutic good from cannabis. From 1 June 2015, cannabidiol has been included under Schedule 4 (S4) Prescription Only Medicine of the Poisons Standard when the cannabinoids component in the preparation for therapeutic use contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis.
Nabiximols, nabilone and dronabinol are listed as Controlled Drugs in S8 of the Poisons Standard. S8 substances also require a prescription from an Australian-registered medical practitioner to obtain and possess within Australia.