Reports

• Manufacturing Quality Branch annual reports
  Our annual reports provide an overview of key statistics, stakeholder engagement, regulatory activity and details about operational changes

Notices

These notices are for sponsors who make GMP clearance applications.

2021 2020 2019 2018

Older, revoked and superseded notices are available in the TGA Internet site archive.

2021

• GMP Clearances: Timeframes for transfers and name change applications
  11 June 2021: Assessments of GMP Clearances are currently being prioritised over administrative changes

2020

• GMP Clearance code tables guidance - Manufacturing steps
  6 July 2020: As part of our on-going process improvement activities and following consultation with the TIWGG we have published GMP Clearance code tables guidance
• GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
  3 July 2020: Information about the TGA’s approach to Good Manufacturing Practice (GMP) inspections and clearances for overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
• GMP clearance questionnaire
  3 July 2020: Complete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal

2019

• GMP Clearance applications using Health Canada evidence
  7 August 2019: Liaison fee is required for all Compliance Verifications (CV) GMP clearance applications using Health Canada Evidence
• GMP Clearance Guidance update (version 18.3)
  27 June 2019: This guidance material has been reviewed to reflect the current processes and provide additional information for sponsors and applicants
• Target processing timeframes for Compliance Verification (CV) GMP clearance applications
  11 June 2019: Target processing timeframes for Compliance Verification (CV) GMP clearance applications submitted from 1st July 2019
• GMP clearance fees
  29 May 2019: Revised GMP clearance fees taking effect 1 July 2019
• GMP clearance guidance update
  29 March 2019: Version 18.2 of GMP clearance guidance
• TGA vs Industry time for GMP clearance applications
  16 January 2019: We have started to accurately capture the processing times of CV applications by consistently applying our stop clock process throughout the entire application

2018

• Updates on GMP clearance application eforms
  11 October 2018: Fixes, including deactivation of 'New Draft Copy' button, will be effective 19 October 2018
• Changed telephone number for enquiries to Manufacturing Quality Branch
  26 September 2018: Streamlining of Manufacturing Quality Branch contact numbers
• Update on the Compliance Verification (CV) GMP clearance applications backlog
  12 September 2018: The TGA has implemented GMP Clearance process improvements and a streamlined compliance verification process
• GMP clearance - Extension application processing timeframes
  23 August 2018: Updates on current processing timeframes of applications to extend GMP clearance
• Updates on GMP clearance application forms
  8 August 2018: Update on extended clearance scope and Letter of access delivery method
• Medicine GMP - revised fees and charges effective 1 July 2018
  18 June 2018: Changes to Medicine GMP fees and charges will become effective 1 July 2018
• Submissions received: Proposal to change the medicine GMP fees and charges
  18 May 2018: Outcome of the TGA's public consulation on proposed Medicine GMP fees and charges published
• GMP clearance process improvements - Post implementation update
  23 April 2018: GMP clearance process - Common issues when completing the online application form in TGA Business Services