In Australia, all medicines go through checks to make sure they are safe, effective and affordable for the people who need them.
There are two main steps
1. Approval for use
- Before any medicine is sold or prescribed in Australia, it must be checked by the Therapeutic Goods Administration (TGA) and listed on their database – The Australian Register of Therapeutic Goods (ARTG)
- The TGA checks that the medication works as intended.
- It ensures that the medicine is safe and made to high quality standards.
- Only medicines that pass this assessment can be supplied in Australia.
2. Government subsidy
- To make prescription medicines cheaper, the government can help pay for them through the Pharmaceutical Benefits Scheme (PBS).
- The Pharmaceutical Benefits Advisory Committee (PBAC) reviews the medicine.
- PBAC checks whether the medicine offers real benefits to patients.
- It also compares the cost and effectiveness of other available treatments.
- If the medicine is beneficial and cost-effective, it is listed on the PBS.
What this means for you
- Only medicines that are safe and work well can be used in Australia.
- Medicines on the PBS are partly paid for by the government, so you spend less.
- This gives you access to treatments that are safe, effective, and worth the cost.
Medication Special Access Schemes
Most medicines and medical products must be checked for quality, safety, and how well they work. They must be listed on the ARTG before they can be sold in Australia.
However, there are situations where you may need treatment that is not yet approved. In these cases, the TGA manages the Special Access Scheme (SAS).
What is the Special Access Scheme (SAS)?
The SAS lets doctors get unapproved treatment for one patient when it’s needed.
Patient categories under SAS:
- Category A: Patients who are very sick and may die within months, or who could die early if they don’t get treatment soon.
- Category B: All other patients who do not meet the Category A criteria.
You can read more about the SAS here: Access to unapproved therapeutic goods for individual patients (Special Access Scheme) | Therapeutic Goods Administration (TGA)
