Notices for manufacturers
6 May 2016
- MRA GMP clearance application processing timelines
6 May 2016: The TGA is working on improving our ability to meet demand by reforming our processes.
- GMP clearance process for MRA countries
17 March 2016: Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application.
- 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
- 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'.
- 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
- New format for TGA conformity assessment certificates
13 October 2011: The new format and design of the conformity assessment certificates incorporate features and improvements