TGA latest news and updates
Australian Public Assessment Reports for prescription medicines (AusPARs)
Thu, 23 May 2019 14:30:00 +1000
Tafenoquine (as succinate) (Kozenis) and Safinamide (Xadago)
Fees and charges: summary from 1 July 2019
Thu, 23 May 2019 12:15:00 +1000
New summary of fees and charges for 2019-20 to take effect from 1 July 2019
Curam Duo 400/57
Wed, 22 May 2019 13:45:00 +1000
Recall – potential for reduced effectiveness
Hair Tonic and Hairpro capsules
Tue, 21 May 2019 15:30:00 +1000
Recall - risk of liver injury
Advertising: Complaints and outcomes
Fri, 17 May 2019 16:30:00 +1000
Application of Stop Clock to Advertising Complaints Cases
TGA actions after review into urogynaecological surgical mesh implants
Fri, 17 May 2019 15:15:00 +1000
Update to Mesh Hub notifying of recent recall actions
TGA continues action against Peptide Clinics Australia for alleged advertising breaches
Fri, 17 May 2019 10:45:00 +1000
Court action continues against Peptide Clinics Australia for alleged advertising breaches
Webinar recording: SME Assist - Permitted indications for listed medicines, March 2019
Thu, 16 May 2019 11:30:00 +1000
This webinar is targeted at small to medium enterprises and any sponsor who is unfamiliar with the current permitted indication requirements
Medical device annual reporting - Sponsor obligations
Wed, 15 May 2019 16:45:00 +1000
Sponsors of Class IIb (implantable), Class III devices, AIMD or Class 4 IVD to submit an annual report to the TGA by 1 October
Delegate-only final decisions and reasons: Agricultural and veterinary chemicals
Tue, 14 May 2019 17:15:00 +1000
Delegate-only scheduling final decisions are now available
Vaccines overview
Tue, 14 May 2019 11:45:00 +1000
An overview of how the TGA regulates vaccines in Australia
TGA presentation: ARCS Australian Pharmacovigilance Regulatory Requirements and Risk Management Plans Summit, 27 March 2019
Mon, 06 May 2019 11:45:00 +1000
Presentations on regulatory requirements for pharmacovigilance and risk management plan compliance.
Breast implants and anaplastic large cell lymphoma
Fri, 03 May 2019 16:30:00 +1000
The TGA has commenced its review and laboratory testing of samples received from the sponsors of breast implants in Australia
Glyceryl trinitrate tablets (Anginine and Lycinate)
Thu, 02 May 2019 18:00:00 +1000
Update 4 - continuing medicine shortage
Metronidazole intravenous infusion 500 mg/100 mL bag
Thu, 02 May 2019 17:30:00 +1000
Update - medicine shortage resolved
Vitex agnus-castus
Thu, 02 May 2019 16:45:00 +1000
Safety advisory – potential for interaction with oral contraceptives
Webinar: How to apply to list a medicine using permitted indications
Wed, 01 May 2019 11:15:00 +1000
This webinar will provide information for sponsors of existing listing medicines to transition to permitted indications
Management and communication of medicine shortages and discontinuations in Australia
Wed, 01 May 2019 10:30:00 +1000
Guidance for sponsors and other stakeholder bodies
Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework
Wed, 01 May 2019 10:00:00 +1000
Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations of supply of mostly prescription medicines
Updates to the Permissible Ingredients Determination for listed medicines
Tue, 30 Apr 2019 11:30:00 +1000
The Therapeutic Goods (Permissible Ingredients) Determination has been updated
Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018
Tue, 30 Apr 2019 10:30:00 +1000
Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018