Regulatory decisions and notices (prescription medicines)

Prescription medicines regulatory decisions

  • Australian Public Assessment Reports for prescription medicines (AusPARs)
    An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application
  • Designation notices
    Before a sponsor can access the Priority review pathway or the Orphan drug fee waiver, they must first be granted a relevant designation by the TGA. This page lists all prescription medicines that are eligible for one or more designations from 1 July 2017
  • Orphan drugs
    An orphan drug is defined as a medicine, vaccine or in vivo diagnostic agent that is: intended to treat, prevent or diagnose a rare disease; or not commercially viable to supply to treat, prevent or diagnose another disease or condition
  • Registration of new chemical entities in Australia
    Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) by the TGA
  • Generic and biosimilar prescription medicines
    Details of generic and biosimilar prescription medicines registered in Australia in 2016
  • New or extended uses of registered medicines
    Over time, the approved therapeutic uses of prescription medicines can change

Prescription medicine notices

2017 2015 2014 2013

Older, revoked and superseded notices are available in the TGA Internet site archive.