TGA latest news and updates
ACSS public statement, 14-15 May 2018
Fri, 22 Mar 2019 16:30:00 +1100
Public statement for the Generic Medicines Working Group face-to-face meeting in Switzerland, May 2018
Breast implant associated cancer (or BIA-ALCL)
Fri, 22 Mar 2019 11:45:00 +1100
Information for consumers and health professionals has been updated
Listed and assessed listed medicines: Application and submission user guide
Thu, 21 Mar 2019 00:00:00 +1100
Guidance updated
Tofacitinib
Thu, 21 Mar 2019 00:00:00 +1100
Clinical study finds increased risk of blood clots in the lungs and of death in rheumatoid arthritis patients on high dose
Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018
Wed, 20 Mar 2019 12:15:00 +1100
Statistics from inspections conducted from 1 September 2017 to 31 December 2018
Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices
Wed, 20 Mar 2019 12:00:00 +1100
Additional Q&A's on use of market authorisation evidence from overseas regulatory bodies for medical devices
Australian Public Assessment Reports for prescription medicines (AusPARs)
Wed, 20 Mar 2019 00:00:00 +1100
Added Live, attenuated, chimeric yellow fever dengue virus (serotypes 1, 2, 3 and 4) (Dengvaxia)
Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
Tue, 19 Mar 2019 13:45:00 +1100
As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS
Requesting variations to your manufacturing licence
Tue, 19 Mar 2019 13:30:00 +1100
As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS
Australian manufacturing licences and overseas GMP certification
Tue, 19 Mar 2019 12:30:00 +1100
As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS
Make Coarser Make Bigger capsules
Mon, 18 Mar 2019 14:30:00 +1100
Make Coarser Make Bigger capsules pose a serious risk to your health and should not be taken.
Brexit - Implications for therapeutic goods in Australia
Mon, 18 Mar 2019 14:15:00 +1100
TGA will implement transitional arrangements for Brexit to ensure minimal interruption in the supply of therapeutic goods in Australia
Consultations on adoption of European Union guidelines in Australia
Mon, 18 Mar 2019 11:00:00 +1100
Consultation on proposed adoption of European Union guidelines. Closing date: 29 April 2019
Updated GMP licence application e-forms
Wed, 13 Mar 2019 11:30:00 +1100
GMP Licence submission e-forms will be updated on the TBS portal from 15 March 2019 to support the revised fees and charges model
'Drop-In Day' (Sydney)
Fri, 08 Mar 2019 15:30:00 +1100
An expression of interest for small to medium enterprises to meet with TGA specialists
Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018
Fri, 08 Mar 2019 13:30:00 +1100
Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018
Public meeting communique: Regulatory options for appropriate access and safety controls for alkyl nitrites
Thu, 07 Mar 2019 17:15:00 +1100
Communique summarising outcomes of the alkyl nitrites public meetings in Sydney and Melbourne
Changes to permissible indications for listed medicines
Thu, 07 Mar 2019 13:45:00 +1100
The Permissible Indications Determination has been updated
Outcomes of the consultation on the draft list of permitted indications
Thu, 07 Mar 2019 11:15:00 +1100
Indications proposed by industry during the 2017 public comment period have been published
Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin
Wed, 06 Mar 2019 16:15:00 +1100
This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019
Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems
Wed, 06 Mar 2019 16:15:00 +1100
This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

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