Section A: Pre-market registration applications referred for advice
At this meeting, the committee's advice was sought on 7 applications under evaluation by the TGA. The applications included:
- one for the registration of a new chemical entity
- one for the registration of a new biological entity
- three seeking extension of indications
- one seeking a major variation to add a new dosing regimen
- one seeking a minor variation to amend the specifications
Further details of the ACM discussion and advice associated with these items are released within the Australian Public Assessment Reports (AusPARs). Please note that there is a delay from when an application was considered at ACM and the publication of the AusPAR. To browse all AusPARs see: AusPAR search
Further information
For further information on the Advisory Committee on Medicines, please visit: Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.