Section A: Submissions for registration
The committee’s advice was sought on 13 new pre-market applications for prescription medicines. The applications (table below) included nine associated with Type A – new Chemical/Biological entities or Biosimilars, 3 associated with Type C – extension and indications and 1 application relating to an extension of indication with associated PI changes.
| Number of applications | Application Type | Main consideration by ACM (among other items) |
|---|---|---|
| 9 | Type A - New Chemical /Biological Entity/Biosimilar | For general consideration |
| 3 | Type C - Extension of indication | For consideration of the broader indication |
| 1 | Type C – Extension of Indication and Type J Changes to the PI | For consideration of the extension of the indication and associated PI changes |
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: Pharmacovigilance
One pharmacovigilance item was referred to the committee for its advice.
The TGA had undertaken a risk-benefit assessment of a medicine previously voluntarily withdrawn from the market.
The ACM provided advice on limitations of published studies, and whether there is now a positive benefit-to-risk balance for an amended indication.
Further information
For further information on the ACM, please visit Advisory Committee on Medicines
or contact the ACM Secretary by email ACM@health.gov.au.