Added Morphine sulfate pentahydrate (Kapanol), Baricitinib (Olumiant) and Liraglutide (Victoza, Saxenda)
We thank those individuals and organisations that lodged submissions for their valuable contribution
Medical device cyber security guidance for industry, users and consumers is now available.
Additional resources added
Exempt disinfectants guidance for industry is now available
Disinfectant Claim guide for industry is now available
Listed disinfectants guidance for industry is now available
Read more about our first provisionally approved medicine
The slides from the Digital Devices Webinar 3 are now available
Registrations for the second GMP Forum in Melbourne on 21 November 2019 are now open
Section 19A database has been updated to include new approvals
What has been updated?
An overview of the updates to the Variation e-form and guidance for variations to prescription medicines
Scheduling committees meeting dates and decisions timeframes
Updates to the prescription medicine variations guidance and e-form
The TGA has developed e-learning modules to assist sponsors to transition to permitted indications
Publication of submissions received to the 'Proposal for the regulation of IVD companion diagnostics' consultation
The ARGB has been restructured and updated in line with new legislative changes
TGA responds to stakeholder feedback and submissions on GCP Inspections Program consultation paper.
Safety claims in advertising may be explicit or implicit - both are prohibited
Fees and charges: summary from 1 July 2019 now in effect
Last month's news & updates
The Therapeutic Goods Administration is part of the Health Products Regulation Group