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ACM meeting statement, Meeting 11, 4 October 2018
Advisory Committee on Medicines
Section A: Submissions for registration
The committee's advice was sought on six new pre-market applications for prescription medicines, as tabulated below.
|Number of applications||Application Type||Main consideration by ACM|
|1||Type A - New Chemical /Biological Entity/Biosimilar||For general consideration|
|3||Type C - Extension of indication||For consideration of broader indication with or without substantiating supportive evidence.|
|2||Type F - Major variation (New Dose Form/New Route of Administration)||For general consideration|
The committee's advice was also sought on one Category 3 application for a registered medicine.
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: Post-Market items referred for advice
No pharmacovigilance items were discussed.