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.
