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
The data submitted with an application is divided into three types.
The composition of the drug substance and the drug product
Sterility data (if applicable)
The impurity content
These data are evaluated by chemists, biochemists, microbiologists, toxicologists and others working for the TGA.
These data are evaluated by toxicologists.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.