We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
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 (18)
- Clinical trials (2)
- Committees and advisory bodies (5)
- Compliance and enforcement (28)
- Cosmetics (2)
- COVID-19 (2)
- Fees and payments (4)
- Import and export (13)
- Labelling and packaging (7)
- Legislation (3)
- Manufacturing (18)
- Medicinal cannabis hub (4)
- Safety monitoring and information (21)
- Scheduling (national classification system) (5)
- Shortages and supply disruptions (15)
- Sunscreens (6)
- Unique Device Identification (UDI) hub (26)
- Vaping hub (1)
- Weight loss products (3)
What's new
191 result(s) found, displaying 101 to 125
-
BlogWhen medicines are in short supply, it can sometimes make patient care more difficult for health practitioners.
We aim to provide clear, timely information to help you access the medicines your patients need during a national medicine shortage. When appropriate, we also make other medicines available so patient care can continue. -
Scheduling decisions (final)This web publication constitutes a notice for the purposes of regulation 42ZCZS and regulation 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
-
User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) scheme Online System (SAS & AP online system) is the preferred method of submission for SAS applications and notifications.
-
ConsultationWe are seeking feedback on proposed changes to improve the regulation of therapeutic sunscreens in Australia.
-
-
GuidanceTimeframes for supplying UDI compliant medical devices in Australia
-
Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989.
-
Media releasesWe have issued 27 infringement notices, totalling $101,412, to a NSW-based individual for the alleged unlawful supply of Melanotan II to Australian consumers in contravention of the Therapeutic Goods Act 1989.
-
News articlesANDEXXA is no longer provisionally approved for use in Australia and has been removed from the Australian Register of Therapeutic Goods (ARTG).
-
User guideLearn how to complete an application for consent to import, supply or export medical devices that do not meet UDI-related Essential Principles.
-
-
PageWe are part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health, Disability and Ageing.
-
Advertising permissionApproval under section 42DF for use of restricted representations by Mainstay Medical Australia Pty Ltd
-
PageSearch the prescribing medicines in pregnancy database.
-
Media releasesWe have led Australia's participation in INTERPOL's Operation Pangea XVIII, a coordinated global action targeting the illegal trade of illicit and counterfeit therapeutic goods.
-
News articlesThe Prescription Medicines in Pregnancy database has been updated to include new entries and amend some existing entries.
-
BlogYou might see a good deal on an overseas website, however, these health products are not approved for supply in Australia and have not been assessed by the TGA for safety, quality or effectiveness. You are not only risking your health, but you may also be left out of pocket if your online purchase is stopped at the border.
-
Prescription medicine decision summaryQalsody has been provisionally approved for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. ALS is a type of motor neurone disease (MND).
-
PageLearn about Required Advisory Statements for Medicine Labels (RASML).
-
Safety updatesCases of medication errors have been identified internationally where tranexamic acid injection was inadvertently administered to the spinal cord, resulting in severe pain, seizures, cardiac arrhythmias and deaths.
-
PageFind out about the shortage of Pegasys (peginterferon alfa-2a) injection.
-
PageFind out how compounded medicines are regulated in Australia, and the responsibilities that apply to people who manufacture, supply or advertise them.
-
Prescription medicine decision summaryFilsuvez (Birch bark dry extract - 84-95% triterpenes) has been approved for the treatment of partial-thickness wounds of the skin associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
-
GuidanceGuidance on the legislative framework that applies to manufacturing, advertising and supplying compounded medicines.
-
Media releasesWe have published new guidance on Manufacturing, supplying and advertising compounded medicines lawfully, to support compliance with Australia’s regulatory requirements.