2017 2016 2015 2013 2012 2011

2017

• PIC/S & EMA consultation
  20 December 2017: PIC/S in partnership with the EMA and WHO releases draft of Annex 1 to the "Guide to GMP for Medicinal Products" for public consultation
• Transition to new GMP requirements for medicinal products
  21 November 2017: A notice about the implications of adopting PE009-13
• Questions & answers on the code of good manufacturing practice for medicinal products
  29 September 2017: Q&A about the PIC/S Guide to Good Manufacturing Practice - 15 January 2009, PE 009-8
• Updated GMP Clearance application forms
  26 September 2017: GMP Clearance application forms now available
• TGA updates GMP Clearance Guidance
  19 September 2017: Updated guidance on GMP Clearance processes & new GMP Clearance Application Assistance Tool (CAAT)
• Update to manufacturing principles for medicines, APIs and sunscreens
  13 September 2017: Notification of intent to adopt the current PIC/S Guide to GMP, PE009-13 as Manufacturing Principles
• GMP clearance process - compliance verification
  11 September 2017: Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application
• Reminder: Planned process improvements for GMP Clearance
  8 September 2017: Reminder about planned process improvements for GMP Clearance in September
• Planned process improvements for GMP Clearance
  15 August 2017: TGA are planning process improvements for GMP Clearance in September 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
• The TGA updates processes for the close-out of on-site GMP inspections
  12 May 2016: The process for conducting post-inspection activities have been reviewed to allow a more efficient resolution of deficiencies and close-out of inspections and to align with international practice

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'.

2012

• Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013
  30 November 2012: Amendments to the EU-Australia MRA (Mutual Recognition Agreements) on conformity assessment to come into force on 1 January 2013

2011

• New format for TGA conformity assessment certificates
  13 October 2011: The new format and design of the conformity assessment certificates incorporate features and improvements