TGA latest news and updates
Alkyl nitrites - public meetings
Thu, 17 Jan 2019 16:30:00 +1100
Finishing times updated: Sydney 31 Jan 2019 and Melbourne 7 Feb 2019
Supplier assessment, approval and qualification for listed and complementary medicines
Thu, 17 Jan 2019 10:30:00 +1100
Updated to be consistent with PE009-13, the PIC/S Guide to GMP
Sampling and testing for listed and complementary medicines
Wed, 16 Jan 2019 14:30:00 +1100
Updated to be consistent with PE009-13, the PIC/S Guide to GMP
Product Quality Reviews (PQRs) for listed and complementary medicines
Wed, 16 Jan 2019 12:45:00 +1100
Updated to be consistent with PE009-13, the PIC/S Guide to GMP
TGA vs Industry time for GMP clearance applications
Wed, 16 Jan 2019 10:45:00 +1100
We have started to accurately capture the processing times of CV applications by consistently applying our stop clock process throughout the entire application
Process validation for listed and complementary medicines
Wed, 16 Jan 2019 10:00:00 +1100
Updated to be consistent with PE009-13, the PIC/S Guide to GMP
Ongoing stability testing for listed and complementary medicines
Wed, 16 Jan 2019 08:30:00 +1100
Updated to be consistent with PE009-13, the PIC/S Guide to GMP
A warning to consumers about the serious health risks relating to e-cigarette liquid
Tue, 15 Jan 2019 16:45:00 +1100
The TGA is alerting consumers to the potential risks of purchasing electronic cigarette liquid
Database of section 19A approvals to import and supply medicines to address medicine shortages
Tue, 15 Jan 2019 14:45:00 +1100
Section 19A database has been updated to include new approvals
Australian Public Assessment Reports for prescription medicines (AusPARs)
Tue, 15 Jan 2019 14:15:00 +1100
Added Ixekizumab (Taltz)
Medicinal gases guidance
Tue, 15 Jan 2019 11:15:00 +1100
Medicinal gases guidance has been updated to reflect expectations of the new PIC/S guide to GMP PE009-13
Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)
Tue, 15 Jan 2019 07:15:00 +1100
These tablets pose a serious risk to your health and should not be taken
Submissions received: Benzocaine: proposed advisory statements for medicines
Mon, 14 Jan 2019 12:00:00 +1100
Submissions received on the Benzocaine: proposed advisory statements for medicines have been published
Video: About the Therapeutic Goods Administration
Mon, 14 Jan 2019 10:45:00 +1100
A short video to take you through who we are and what we do
Consultation: Good Clinical Practice Inspections Program
Fri, 11 Jan 2019 14:45:00 +1100
The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019
Breast implants and anaplastic large cell lymphoma
Fri, 11 Jan 2019 14:15:00 +1100
Update - additional confirmed cases of anaplastic large cell lymphoma
Consultation: Proposed amendments to the Poisons Standard - ACCS meeting, March 2019
Thu, 10 Jan 2019 09:00:00 +1100
Invitation to comment on proposed amendments to the Poisons Standard - ACCS, March 2019 (late addition to the published agenda). Closing date: 8 February 2019
SME Assist workshop: 'Meeting Your Obligations' (Adelaide)
Wed, 09 Jan 2019 10:15:00 +1100
A face-to-face workshop covering the basics of regulation
Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia
Mon, 07 Jan 2019 17:30:00 +1100
The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019
Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy
Mon, 07 Jan 2019 17:00:00 +1100
The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019
Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
Mon, 07 Jan 2019 16:30:00 +1100
We seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Closing date: 18 February 2019

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