The Australian Public Assessment Report (AusPAR) is an assessment report provided by the Therapeutic Goods Administration (TGA) to demonstrate the transparency of registration process of the prescription medicines. The purpose of the report is to provide information about the pre-registration process and scientific rationale regarding the decision of the TGA to approve or disapprove the drug. AusPAR is similar to that of the European Public Assessment Report (EPAR) published by the European Medicines Agency (EMA). In case a Product Information (PI) document is also approved, it will also have to be included in the AusPAR.
The AusPAR is prepared by the TGA with the help of the sponsor responsible for the registration application. The reports are drafted as per the guidelines published by the TGA under the AusPAR for prescription medicines guidance document.
Requirement of AusPARs
AusPAR is not required for all the prescription medicines being placed in the Australian market. If the significance of the changes made to the formulation of an existing medicine is low, it does not require an AusPAR to be submitted with it.
AusPAR will be required for applications of Category 1 and 2 that has the following attributes:
- Type A – New chemical or biological entity
- Type A – New salt/ester of previously approved active ingredients
- Type A – Biosimilar medicine
- Type B – New combination of previously approved active ingredients
- Type C – Extension of indications
Preparing an AusPAR
AusPARs is authored post the completion of the registration process of any prescription drug. It incorporates information collected from the key documents presented during the registration process for the evaluation, expert advisory and decision phases. The content of AusPAR vary from submission to submission and depends on the evidence supporting the submission. Generally, an AusPAR has the following sections:
- Assessment summaries for the relevant areas along with information related to quality and manufacturing, nonclinical, clinical and pharmacovigilance requirements
- Conclusions based on the expert advisory group(s) advice and risk benefit analysis
- Product sponsor's response to the overview or request for expert advice
An AusPAR is published within 12 weeks of the new entry registered with the Australian Register of Therapeutic Goods (ARTG).
Would you like to know more about AusPAR and other reports published by the TGA, reach out to Freyr at email@example.com.