Section A: Pre-market registration applications referred for advice
At this meeting, the committee’s advice was sought on 8 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
- three seeking major variations (change in dose form, route of administration and/or new strength)
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.