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 manufacturers of medicines, biologicals and blood, blood components and HPCs.

For notices about manufacturing medical devices, go to Regulatory decisions and notices (Medical devices and IVDs)

2020 2019 2018

Older, revoked and superseded notices are available in the TGA Internet site archive.

2020

• TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
  3 July 2020: Information to assist overseas manufactures who may undergo a remote Good Manufacturing Practice (GMP) inspection during the COVID-19 pandemic
• 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
• Transition to new GMP requirements for medicinal products
  22 June 2020: A notice about the implications of adopting the PIC/S Guide to GMP PE009-14
• Exemption to enable timely access to radiopharmaceuticals and RAI
  6 May 2020: Information on an exemption for radiopharmaceuticals that facilitates interstate supply during COVID-19
• Update to Manufacturing Principles for medicines, APIs & sunscreens
  4 May 2020: The TGA is adopting the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products

2019

• Updated GMP licence application e-forms
  13 March 2019: GMP Licence submission e-forms will be updated on the TBS portal from 15 March 2019 to support the revised fees and charges model

2018

• Changed telephone number for enquiries to Manufacturing Quality Branch
  26 September 2018: Streamlining of Manufacturing Quality Branch contact numbers
• 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
• Implementation of the PIC/S guide to GMP PE009-13
  2 January 2018: On 1 January 2018 the TGA adopted new manufacturing principles to be observed by manufacturers of medicines and active pharmaceutical ingredients