2017 2016 2015 2013

Older, revoked and superseded notices are available in the TGA Internet site archive.

2017

• Electronic signatures to replace 'wet ink' signatures
  5 July 2017: All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and no longer contain a wet ink signature
• GMP clearance process - Fees for compliance verification GMP clearance applications
  21 June 2017: Update regarding GMP clearance Compliance Verification (CV) fees
• Target processing timeline for MRA GMP clearance applications
  24 April 2017: Update on target processing timeline for MRA GMP clearance applications
• Withdrawal of "under review" GMP clearance applications that are no longer required
  5 April 2017: Update on compliance verification GMP clearance applications - Withdrawal of "under review" GMP clearance applications that are no longer required
• Update on compliance verification GMP clearance applications
  5 January 2017: Common issues with compliance verification GMP clearance applications

2016

• Online payment of licence application fees by biological manufacturers
  20 October 2016: We have identified a billing issue in our online systems
• Revised risk management strategy for manufacturers of medicines and blood, tissues and cellular therapies
  30 September 2016: Update to the manufacturer risk management framework and reinspection frequencies for medicines, blood, tissues and cellular therapies
• MRA GMP clearance application processing timelines
  6 May 2016: The TGA is working on improving our ability to meet demand by reforming our processes
• GMP clearance process for MRA countries
  17 March 2016: Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application

2015

• Issues affecting documentation attached to some GMP clearance applications
  30 July 2015: The TGA has become aware of issues affecting documentation attached to some GMP clearance applications

2013

• Revised code of GMP for human blood and tissues
  4 June 2013: The Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 commences on 31 May 2013
• Manufacturer audits are now termed inspections
  29 April 2013: The TGA is changing its terminology - the word 'inspection' is replacing the word 'audit'.