We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Section A: Submissions for registration
The advice of the Advisory Committee on Medicines (ACM) was sought on eleven new pre-market applications for prescription medicines, as tabulated below.
| Number of applications considered | Application Type | Main consideration by ACM |
|---|---|---|
| 5 | Type A - New chemical /biological entity | For general consideration |
| 1 | Type B - New combination of active ingredients | For general consideration |
| 1 | Type B - New combination of active ingredients and Type A - New chemical entity | For general consideration |
| 3 | Type C - Extension of indication | For consideration of broader indication with or without substantiating supportive evidence. |
| 1 | Type C - Extension of indication and Type F - Major variation (strength) | For general consideration |
Further details of the ACM discussions and advice associated with pre-market items are released within the Australian Public Assessment Reports (AusPARs) for each new active. Please note that there is a delay from when an application was considered at ACM, and the publication of the AusPAR. Browse all AusPARs.
Section B: Post-Market items referred for advice
No post-market items were referred for advice.
Further information
For further information on the ACM, please visit Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.