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This page links to our database of applications for new medicines or new uses for existing medicines that are currently under evaluation by us. The list of medicines under evaluation is updated each month.
Information on three types of applications is included:
- Application type A: applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia
- Application type B: applications for a 'new combination', where two or more already approved medicines are combined into a single product
- Application type C: applications for a 'new indication', or additional therapeutic use, for an already approved medicine
Applications for new generic and biosimilar medicines are excluded from this list.
The entry for each application includes:
- the proposed tradename
- the applicant name
- the active ingredient(s)
- a summary of the proposed indication(s)
- the application type
Publication commenced for applications accepted for evaluation from January 2021. The list only includes medicines that have been accepted for evaluation and are under evaluation with a cut-off the day the report is completed. Entries are removed from the list as part of the monthly update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.
You can see if an application has been approved by searching the Australian Register of Therapeutic Goods (ARTG).
Further information about decisions (approved and rejected) and some withdrawals[1] is available in form of an Australian Public Assessment Report (AusPAR) or a Decision summary.
IMPORTANT INFORMATION
Medicines are listed on this page when they are accepted for evaluation by us. It is important to view the information in the context of the following.
Evaluation does not guarantee registration
The list only includes information on medicines that are currently under evaluation for quality, safety and efficacy and are pending the decision to register the medicine on the ARTG.
Not all medicines that are accepted for evaluation are approved by us. 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.
Evaluation does not guarantee PBS listing
While entry on the ARTG provides for legal supply of a medicine in Australia, the listing of the medicine on the Pharmaceutical Benefits Scheme (PBS) facilitates subsidised access to medicines. PBS listing is subject to a separate application process that is also initiated by the company and typically follows the registration on the ARTG. For information about PBS listings visit the PBS website.
Each year, we accept approximately 100 major innovator applications for new medicines or new uses of medicines.
Footnotes
| [1] | If the submission is withdrawn prior to our receipt of the sponsor's response to the Delegate's overview or request for expert advice, then an AusPAR will not be published. |
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Applications under evaluation
Where relevant, the database information notes the registration process:
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Provisional registration: involves early access to vital and life-saving medicines through time-limited registration
Current applications database
Prescription medicines under evaluation