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Older, revoked and superseded notices are available in the TGA Internet site archive.

2017

• Explanatory document for Seasonal influenza vaccines – quality module
  30 August 2017: Sponsors are invited to provide comment on this guidance by 26 October 2007 (8 weeks from publication date)
• Priority review pathway: prescription medicines
  26 June 2017: Implementation of a Priority review pathway for the registration of novel prescription medicines
• Orphan drug program reforms
  26 June 2017: Implementation of reforms to the orphan drugs program
• Reform of the Orphan Drug Program - Transition arrangements
  1 May 2017: Letter to sponsors about transition arrangements for changes to the Orphan Drug Program

2015

• Prescription medicines: pre-submission pilot
  14 December 2015: The TGA is introducing pilot changes to the pre-submission phase of the prescription medicines registration process
• Receiving prescription medicine streamlined submission evaluation reports by email
  14 April 2015: The TGA case management team is sending prescription medicine streamlined submission evaluation reports via email to organisations that have registered for secure email

2014

• Updated pre-submission planning form
  9 May 2014: Amendments have been made to the prescription medicines pre-submission planning form
• Cessation of acknowledgement letters for Category 3 submissions
  22 April 2014: Applicants of Category 3 prescription medicine submissions will no longer be issued with an acknowledgment letter advising of the receipt of their submission

2013

• Business process review: minor variations to prescription medicines - for sponsors
  23 August 2013: Proposed changes to the process for making certain minor variations to ARTG entries for registered prescription medicines
• Electronic data requirements for Category 3 application dossiers
  18 July 2013: From 1 January 2014 the TGA asks that all dossiers are also provided in electronic form