TGA latest news and updates
TGA cracking down on non-compliant advertising of bioresonance and similar devices
Fri, 16 Aug 2019 14:45:00 +1000
The TGA has commenced work on a sector-wide compliance activity relating to the advertising of bioresonance devices
Database of section 19A approvals to import and supply medicines to address medicine shortages
Fri, 16 Aug 2019 10:30:00 +1000
Section 19A database has been updated to include new approvals
Advertising directions notices
Thu, 15 Aug 2019 17:00:00 +1000
Advertising direction notices issued to Auzsupps Pty Ltd and ESR You Pty Ltd
Australian Public Assessment Reports for prescription medicines (AusPARs)
Thu, 15 Aug 2019 11:00:00 +1000
Added Tiotropium (Braltus), Denosumab (Prolia) and Inotuzumab ozogamicin (Besponsa)
Submissions received: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
Wed, 14 Aug 2019 15:30:00 +1000
Submissions received on the Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia have been published.
Upcoming changes to the Permissible Indications Determination
Wed, 14 Aug 2019 15:15:00 +1000
A complete list of pending changes to the Permissible Indications Determination
'Meeting your obligations' workshop Perth
Wed, 14 Aug 2019 12:45:00 +1000
Register your interest for the SME Assist workshop in Perth
Webinar: Essential Principles to software
Tue, 13 Aug 2019 17:45:00 +1000
This webinar will provide an introduction to how the Essential Principles can be applied to medical device software
Prescription medicines: new or extended uses, or new combinations of registered medicines
Mon, 12 Aug 2019 16:00:00 +1000
8 medicine registrations added
Prescription medicines: registration of new generic medicines and biosimilar medicines
Mon, 12 Aug 2019 16:00:00 +1000
8 medicine registrations added
Prescription medicines: registration of new chemical entities in Australia
Mon, 12 Aug 2019 16:00:00 +1000
2 medicine registrations added
Paclitaxel-coated products used in the peripheral arteries
Mon, 12 Aug 2019 00:15:00 +1000
Safety information: regulators review balloon and stent devices used to unblock blood vessels in the legs
Hong Kong Tianli Biological – power tablet
Fri, 09 Aug 2019 15:30:00 +1000
Hong Kong Tianli Biological - Power tablets pose a serious risk to your health and should not be taken
Bali Mojo capsules
Fri, 09 Aug 2019 15:30:00 +1000
Bali Mojo capsules pose a serious risk to your health and should not be taken
Public submissions on scheduling matters referred to the ACMS #26, ACCS #24 and Joint ACMS-ACCS #21 meetings held in March 2019
Fri, 09 Aug 2019 09:30:00 +1000
Public submissions in response to the March 2019 ACMS/ACCS/Joint interim decision
Australian traveller fined for importing unapproved products in luggage
Wed, 07 Aug 2019 12:45:00 +1000
An individual has been fined for the alleged importation of unapproved cosmetic products after returning from an overseas trip to China
Second Industry Forum on Good Manufacturing Practice - GMP²
Wed, 07 Aug 2019 09:45:00 +1000
'Meeting your obligations' workshop to precede the GMP Forum in Melbourne, November 2019
Medical device patient information leaflets and implant cards
Wed, 07 Aug 2019 08:45:00 +1000
Update to e-leaflets and to correct the dates sponsors and manufacturers are to comply with implant cards or leaflets
Best practice for Patient Information Leaflets and Patient Implant Cards
Wed, 07 Aug 2019 08:45:00 +1000
In addition to the legislated requirements, there are other features of leaflet and card design that can be very helpful for patients
GMP Clearance applications using Health Canada evidence
Wed, 07 Aug 2019 08:15:00 +1000
Liaison fee is required for all Compliance Verifications (CV) GMP clearance applications using Health Canada Evidence
Breast implants and anaplastic large cell lymphoma
Tue, 06 Aug 2019 15:45:00 +1000
Update – Sponsor initiated Recall and Hazard Alert regarding Allergan macro-textured breast implants and tissue expanders

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