The role of TGA Australia in regulating Medicinal Cannabis
From October 2016, legislation was passed that allows the legal supply of medical cannabis products. However in Australia, before doctors can start freely prescribing a newly-legalised medicine like marijuana, it must firstly be tested via extensive clinical trials and subsequently entered onto a federally-approved list (called the Australian Register of Therapeutic Goods or ARTG). Since clinical trials can sometimes take years, the government offers several interim pathways so patients can access the drug (ie medicinal cannabis) in the meantime. This whole regulated process is run by the government body known as the Therapeutic Goods Administration (TGA).
Currently the TGA’s fastest access pathway for medicinal cannabis is the Special Access Scheme Category B (or SAS B). Under this scheme, a specialist doctor must submit a patient request, after which approval from the TGA is given within 1 to 6 days on a case-by-case basis. Submission forms can be downloaded from the TGA website, or the CannabisAccess medical cannabis portal may be used for online submissions.
If a specialist has a large volume of patients, then applying for TGA approval for each patient may become overly time consuming. In this case, we recommend that doctors apply to become Authorised Prescribers. Under this scheme, TGA approval will be given so that doctors can prescribe a medical cannabis product to a class of patients with similar conditions (such as epilepsy).
The full list of access pathways that the TGA Australia provides for unapproved medicines is shown in the diagram below:
In some Australian states, approval to prescribe medicinal cannabis must also be given by the local State Health Authority. For more information on each state, see below: