The TGA evaluates the safety, quality and efficacy of prescription medicines before they are approved for registration in the Australian Register of Therapeutic Goods (ARTG)
Not all medicines that are accepted for evaluation are approved by the TGA. Whether a medicine is approved or not depends on the outcomes of our assessment of the application.
The medicine's indications can also change following our evaluation of the data. For more information visit our web page on new registrations
Data evaluation
The data submitted with an application is divided into three types.
- Quality data
- The composition of the drug substance and the drug product
- Batch consistency
- Stability data
- Sterility data (if applicable)
- The impurity content
- These data are evaluated by chemists, biochemists, microbiologists, toxicologists and others working for the TGA.
- Nonclinical data
- Pharmacology data
- Toxicology data
- These data are evaluated by toxicologists.
- Clinical data
- Mostly results of clinical trials
- These data are usually evaluated by a medical doctor.
The data set submitted is evaluated by technical staff with the relevant expertise and several, separate evaluation reports may be produced. Each evaluation area has the opportunity to ask the sponsors questions about the data submitted.
Once each evaluation area has assessed the sponsor's response, final evaluation reports are prepared and reviewed internally before they are authorised and sent to the sponsor. The sponsor then has the opportunity to make comments.
For more details go to Australian regulation of prescription medical products