Learn how the TGA regulates medicines and find medicine resources.
- Australian Public Assessment Reports for prescription medicines (AusPARs)
An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application.
- Codeine information hub
From 1 February 2018, medicines that contain low-dose codeine will no longer be available without prescription in pharmacies.
- Labelling changes: information for health professionals
Information for health professionals about changes to medicine labels.
- Medicines and TGA classifications
Australia has a two-tiered system for the regulation of medicines, including complementary medicines.
- Product Information (PI)
A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription, some non-prescription medicines and some biologicals.
- Availability of morphine sulfate injection products: Information for health professionals
All strengths of DBL Morphine Sulfate Injection products are in limited supply due to manufacturing issues resulting in delays to packaging.
- Black Triangle Scheme
The Black Triangle Scheme provides a simple means for practitioners and patients to identify certain types of new prescription medicines, and to encourage the reporting of adverse events associated with their use.
- Cough and cold medicines for children - changes
Advice to consumers and health professionals on cough and cold medicines for children.
- Fast track approval pathways for prescription medicines
Fast track approval aims to get prescription medicines that treat serious and life-threatening conditions to patients earlier.
Pregnancy and medicines
- Prescribing medicines in pregnancy database
This database is intended to provide information to health professionals planning the medical management of pregnant patients or patients intending to become pregnant. It is not presented as medical advice to health professionals or the public.
- Registration of medicines for the medical termination of early pregnancy
The TGA has included Mifepristone (RU 486) on the Australian Register of Therapeutic Goods (ARTG) as of 29 August 2012.
- Medicine Shortages Information Initiative
The Medicine Shortages Information Initiative provides information about prescription medicine shortages in Australia.
- Accessing medicines during a medicines shortage
The TGA can approve the import and supply of a medicine that is not included in the ARTG under section 19A of the Act.