Notices for manufacturers
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)
Older, revoked and superseded notices are available in the TGA Internet site archive.
- Transition to new GMP requirements for medicinal products
21 November 2017: A notice about the implications of adopting PE009-13
- 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
- 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
- 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
- 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
- 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'.