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 for open consultations.
- joining any upcoming events.
This page is in Beta testing. We welcome your feedback and suggestions as we look to improve this page.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- Advertising (7)
- Committees and advisory bodies (3)
- Compliance and enforcement (16)
- Cosmetics (1)
- Fees and payments (1)
- Import and export (10)
- Labelling and packaging (1)
- Legislation (2)
- Manufacturing (12)
- Safety monitoring and information (12)
- Shortages and supply disruptions (11)
- Sunscreens (6)
- Unique Device Identification (UDI) hub (15)
- Vaping hub (2)
What's new
98 result(s) found, displaying 1 to 25
-
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.
-
Prescription medicine decision summaryNiktimvo is approved for the treatment of chronic graft-versus host disease (cGVHD). Niktimvo contains the active ingredient axatilimab.
-
Prescription medicine decision summaryOrserdu is approved for the treatment of advanced breast cancer in postmenopausal women, and men. Orserdu contains the active ingredient elacestrant.
-
PageLearn about the requirements for advertising therapeutic goods in specific circumstances, such as social media, and for specific types of products, like weight loss injections.
-
PageKey information about the shortage for patients, carers and health care professionals
-
PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
-
News articlesSponsors and manufacturers intending to export medicines and medical devices to Indonesia should be aware of new and emerging halal certification requirements under Indonesia’s Halal Product Assurance framework.
-
FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
-
Australian public assessment report (AusPar)Audenz (influenza virus haemagglutinin) is indicated for active immunisation against influenza A in persons from 6 months of age and older in an officially declared pandemic.
-
GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.
-
Prescription medicine decision summaryRedemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS).
-
BlogDo you know that there are strict rules when it comes to advertising therapeutic goods? If you see an ad that looks like it’s breaking the rules, report it using our online portal.
-
PageAdvice on the implications of Brexit for therapeutic goods supply in Australia.
-
PageMedical devices priority applicant determination notices and eligibility for priority review pathway.
-
PageTGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries.
-
GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
-
GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
-
DatasetSearch approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
-
PageInformation and updates about the shortages of cyclophosphamide and ifosfamide injections.
-
Meeting statementsAdvisory Committee on Vaccines meeting statement 56
-
PageFind out about our compliance review activities for listed medicines and how to avoid common compliance issues.