What's new
This page lists items that we have published for the first time or updated in the last 7, 30 or 60 days. Use the filters to narrow results by audience, product type, content type or topic.
You can also stay informed by:
- subscribing to our updates to receive same-day notification emails on safety information, scheduling updates or media releases.
- checking our consultation hub.
- joining any upcoming events.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- Advertising (7)
- Breast implant hub (1)
- Committees and advisory bodies (1)
- Compliance and enforcement (12)
- Fees and payments (2)
- Import and export (2)
- Labelling and packaging (8)
- Legislation (17)
- Manufacturing (3)
- Metal-on-metal hip replacement implants hub (1)
- Peptide products (1)
- Safety monitoring and information (12)
- Scheduling (national classification system) (7)
- Shortages and supply disruptions (8)
- Sunscreens (2)
- Unique Device Identification (UDI) hub (6)
- Urogynaecological (transvaginal) surgical mesh hub (1)
- Vaping hub (1)
What's new
114 result(s) found, displaying 26 to 50
-
Media releasesWe seeking feedback on a proposal to strengthen the labelling of low-risk products that contain vitamin B6.
-
Safety updatesHealth care professionals should check product-specific instructions when preparing and administering vaccines.
-
Meeting statementsAdvisory Committee on Complementary Medicines meeting statement for 30 July 2026
-
Advertising permissionApproval under section 42DF for use of restricted representations by Side Sleeper Pty Ltd
-
Advertising permissionApproval under section 42DF for use of restricted representations by Swallowing Technologies Ltd
-
PageThe shortages of most methylphenidate modified-release products have resolved.
-
PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
-
ConsultationHave your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Chemicals Scheduling (ACCS).
-
ConsultationHave your say about proposals to amend the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC). These will be considered at the next meeting of the joint meeting of Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS).
-
ConsultationHave your say about proposals to amend the Poisons Standard in relation to nitrous oxide. These will be considered at the next meeting of the joint meeting of Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS).
-
Australian Public Assessment Report (AusPAR)Exdensur is indicated as add-on maintenance treatment for inadequately controlled severe asthma in patients aged 12 and older with type 2 inflammation, and as an add-on therapy with intranasal corticosteroids for the treatment of adults with inadequately controlled CRSwNP
-
PageView published decisions relating to the granting of licences for the manufacture of therapeutic goods in Australia.
-
Regulatory decision noticesWe have added our recent decisions to the list of Australian manufacturers licensed by the TGA.
-
Advertising permissionApproval under section 42DF for use of restricted representations by Smith & Nephew Pty Ltd
-
Meeting statementsOutcomes following the Australian Influenza Vaccine Committee meeting held on Wednesday 7 October 2026.
-
PageWe are reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the ARTG.
-
FormsUse this form to apply for approval of a new Technical Master File (TMF), an annual update to an approved TMF, or a significant update to an approved TMF.
-
FormsUse this form to apply for approval of a new Type II Plasma Master File (PMF), an annual update to an approved Type II PMF, or a significant update to an approved Type II PMF.
-
PageAll medicines included in the Australian Register of Therapeutic Goods (ARTG) must include the relevant AUST number on the label.
-
PageUnderstand how New Approach Methodologies (NAMs) can support therapeutic good development and regulatory decision-making.
-
GuidanceThis guidance explains how sponsors and manufacturers should prepare and maintain a Technical Master File (TMF) for blood, blood components, and haematopoietic progenitor cells. It outlines TMF requirements, submission processes, evaluation pathways and change management requirements.
-
GuidanceThis guidance explains how sponsors should prepare, submit and maintain a Type I Plasma Master File (PMF) for therapeutic goods for supply in Australia that contain or are produced from human blood or plasma.
-
GuidanceThis guidance explains how sponsors should prepare, submit and maintain a Type II Plasma Master File (PMF), for export only therapeutic goods that contain or are produced from human blood or plasma.
-
GuidanceThis guidance explains the regulatory requirements for supplying therapeutic goods that contain, or are produced from, human plasma.
-
TGA laboratory testing reportsImmunoglobulins, commonly known as antibodies, are specialised glycoproteins produced by plasma cells in response to the presence of antigens – foreign substances such as viruses, bacteria, or toxins.