Section A: Submissions for registration
The committee's advice was sought on 10 new pre-market applications for prescription medicines. The applications (table below) included four associated with Type A – new Chemical/Biological entities or Biosimilar, 4 associated with Type C – extension and indications, one application relating to an extension of indication with new directions for use, and one application relating to a generic medicine (Type D).
| Number of applications | Application Type | Main consideration by ACM (among other items) |
|---|---|---|
| 4 | Type A - New Chemical /Biological Entity/Biosimilar | For general consideration |
| 4 | Type C - Extension of indication | For consideration of broader indication with or without substantiating supportive evidence. |
| 1 | Type F – New directions for Use and Type C Extension of indications | For general consideration |
| 1 | Type D -Generic medicine | For consideration relating to the product formulation |
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: Safety
No pharmacovigilance items were discussed.
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.