TGA latest news and updates
Prescription medicines: registration of new chemical entities in Australia
Fri, 16 Nov 2018 17:45:00 +1100
2 medicines added
Prescription medicines: new or extended uses, or new combinations of registered medicines
Fri, 16 Nov 2018 16:45:00 +1100
3 medicine registrations added
Prescription medicines: registration of new generic medicines and biosimilar medicines
Fri, 16 Nov 2018 16:45:00 +1100
7 medicine registrations added
Medicine shortages reporting reforms: What you need to know (webinar)
Fri, 16 Nov 2018 09:30:00 +1100
From 1 January 2019, sponsors of prescription and some over-the-counter medicines will be required to report all medicine shortages
Australian Public Assessment Reports for prescription medicines (AusPARs)
Thu, 15 Nov 2018 10:45:00 +1100
Added Alirocumab (Praluent) and Brexpiprazole (Rexulti)
ACM meeting statement, Meeting 11, 4 October 2018
Fri, 09 Nov 2018 15:30:00 +1100
The Advisory Committee on Medicines meeting statement for Meeting 11 is now available
TGA presentation: Generic and Biosimilar Medicines Association (GBMA) meeting, 2 November 2018
Fri, 09 Nov 2018 14:30:00 +1100
Short presentation on the ACSS Consortium, the Generic Medicines Working Group and the Generic Medicines Work-Sharing Trial
Medical Devices Safety Update, Volume 6, Number 6, November 2018
Fri, 09 Nov 2018 11:30:00 +1100
Standards minimise risk of misconnections; eltrombopag interference with test results; amniotic fluid tests
SQ-RX Model 1010 Pulse Generator – used with Boston Scientific S-ICDs
Thu, 08 Nov 2018 12:00:00 +1100
Hazard alert – potential battery issue
ACMD meeting statement, Meeting 43, 11 October 2018
Wed, 07 Nov 2018 14:00:00 +1100
Advisory Committee on Medical Devices meeting statement
AEMS guidance for health professionals
Wed, 07 Nov 2018 12:45:00 +1100
Adverse Event Management System - instructions on using the new system for health professionals
AEMS guidance for sponsors
Wed, 07 Nov 2018 12:45:00 +1100
Adverse Event Management System - instructions on using the new system for sponsors
Communication to stakeholders: Autologous human cells and tissues (HCT) products
Tue, 06 Nov 2018 11:30:00 +1100
Important information about potential impact of regulation changes that came in force on 1 July 2018
Database of section 19A approvals to import and supply medicines to address medicine shortages
Mon, 05 Nov 2018 11:00:00 +1100
The Section 19A database has been updated to include new approvals
Updating medicine ingredient names
Fri, 02 Nov 2018 17:00:00 +1100
New communication materials available
How to determine if your product should be included in the ARTG
Fri, 02 Nov 2018 10:15:00 +1100
Assistance for sponsors with products included in the ARTG as Class I medical devices to decide if their products are included correctly
Comparable Overseas Reports (COR-A) pathway - First registration decision
Fri, 02 Nov 2018 08:45:00 +1100
Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway
Puritan Bennett 980 Series Ventilator
Thu, 01 Nov 2018 10:45:00 +1100
Update to information
Annual Charge Exemption Scheme - entries declaring $0 turnover
Thu, 01 Nov 2018 08:30:00 +1100
Publication of the 2017-18 confirmed annual charge exemptions
Update on the Australia-Canada Mutual Recognition Agreement
Thu, 01 Nov 2018 08:00:00 +1100
Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement
Therapeutic goods advertising: Update 31 October 2018
Wed, 31 Oct 2018 23:45:00 +1100
The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019

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