Regulatory decisions and notices

2 April 2013

Presciption 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
• 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

Prescription medicine notices

• Business process review: minor variations to prescription medicines - for sponsors
  Proposed changes to the process for making certain minor variations to ARTG entries for registered prescription medicines
• Electronic-only (eCTD) submissions are one step closer
  On 28 September 2012, the TGA released a request for tender for software and services to assist the TGA in processing data electronically
• Periodic Safety Update Reports (PSURs) for well-established active substances or the registration of a generic
  The TGA has decided to vary the conditions of specific registration for the need for the submission to TGA of PSURs that have been required for products in certain categories