The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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.
Older, revoked and superseded notices are available in the TGA Internet site archive.
2023
- GMP Clearance: Extension processing times
17 May 2023: Current delays in application processing timeframes to extend GMP Clearances. - GMP Clearance: Additional countries added to MRA pathway
20 March 2023: Additional countries will be added to the MRA assessment pathway for GMP clearance from 20 March 2023.
2022
- GMP Clearance: Temporary changes to target processing times
21 October 2022: Temporary update to the target timeframes for assessment of Compliance Verification (CV) GMP Clearance applications
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 consultation 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