Section A: Submissions for registration
The committee’s advice was sought on 13 new pre-market applications for prescription medicines. The applications (table below) included seven for Type A – new Chemical/Biological entities, four associated with Type C – extension and indications, a major variation (Type F) and a new generic medicine application (Type A).
| Number of applications | Application Type | Main consideration by ACM (among other items) |
|---|---|---|
| 7 | Type A - New Chemical /Biological Entity | For general consideration |
| 1 | Type C - Extension of indication | For consideration of broader indication without substantiating supportive evidence. |
| 2 | Type C - Extension of indication | For general consideration |
| 1 | Type C - Extension of indication | For consideration of the modified indication, the limited evidence and associated PI |
| 1 | Type D - New generic medicine | For general consideration |
| 1 | Type F - Major variation (dosage) and (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 delay from when an application was considered at ACM, and the publication of the AusPar. Browse all AusPARs.
Section B: Post-Market items
No items were referred to ACM.
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.