Fast track approval pathways for prescription medicines
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Prescription medicines overview
18 November 2019
What is a prescription medicine?
A prescription medicine is a medicine that can only be made available to a patient on the written instruction of an authorised health professional. Examples of prescription medicines include blood pressure tables, cancer medicine and strong painkillers.
All prescription medicines are registered medicines and can be identified by an AUST-R number on the label.
Why is a medicine prescription only?
A medicine is classified as prescription only because of various factors, including:
- the risk associated with its use
- how it is to be taken (for example if it is to be injected)
- the potential for misuse.
How does the TGA approve prescription medicines for use?
For a prescription medicine to be supplied in Australia, a drug company must first apply to the TGA for approval of the medicine and provide comprehensive evidence of the medicine's quality, safety and efficacy.
This evidence can take many years to gather and includes clinical trials to make sure that the medicine works as intended. Clinical trials also discover potential risks of the medicine. You can find out more about clinical trials at the Australian clinical trials website.
Our technical experts assess all of the supplied evidence, and request more if necessary. If the overall benefit of the medicine is found to outweigh the risks when used in appropriate circumstances, and the quality is confirmed then the medicine will be approved.
It can take some time to review all the information about the medicine. Under our standard approval pathway, it can take up to 11 months for us to make a decision. However, we have fast track approval pathways for certain prescription medicines. These pathways aim to get some prescription medicines for serious and life-threatening conditions to patients sooner.
If we approve a prescription medicine we will register it on the Australian Register of Therapeutic Goods (ARTG). The ARTG is maintained by the TGA.
Once a prescription medicine is registered on the ARTG, it can be supplied by the drug company in Australia.
How do I know my prescription medicine is safe?
We monitor the safety of prescription medicines after we have approved them. When a prescription medicine is first approved and registered, information about its safety and efficacy when used with patients is mainly available from clinical trials. Clinical trials have limited numbers of people so we may not have the full picture of the medicine's safety. Some safety issues may be so rare that it takes thousands of people using the medicine for a long time before they can be identified. This is why we continue to collect information about the medicine after it is approved and supplied.
We collect information on reported side effects and publish details on our website, which helps everyone know what to look out for. You can search for information that we have received on a prescription medicine's safety in our Database of Adverse Event Notifications.
Reporting adverse events helps make medicines safer for everyone. If you know of an issue or problem from a medicine, you should tell us. You can ask a doctor or pharmacist to report on your behalf, or you can report the problem directly to us.
How can I find more information about a prescription medicine?
You can find more information about a prescription medicine such as ingredients and possible side effects by looking at the Consumer Medicine Information (CMI). You can find, view and save CMIs on your phone or tablet by downloading the MedSearch app.
The CMI is written for patients and contains information on the safety and efficacy of a medicine including how the medicine works, dosage, side effects, and interactions with food or other medicines.
What are the state and territory laws on prescription medicines?
Each Australian state and territory has laws regarding which health professionals can write a prescription, which medicines they can prescribe and in what circumstances. To find out more about the state and territory laws for prescription medicines, contact the state and territory medicine units.
How does the Government subsidise medicines?
Subsidies are determined and administered by a different section of the Department. For more information about how prescription medicines are subsidised visit the Department of Health's Pharmaceutical Benefits Scheme webpage.