Section A: Pre-market registration applications referred for advice
At this meeting, the committee's advice was sought on 5 applications under evaluation by the TGA. The applications included:
two for the registration of a new chemical entity
two for the registration of a new biological entity
one seeking extension of indications
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
