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If you're a sponsor, it's important to be aware of the global issue of nitrosamine impurities in medicines. Find out what steps you should take.

This International Coalition of Medicines Regulatory Authorities (ICMRA) statement provides the general public with important information regarding the safety of COVID-19 vaccines, which have now been in use for more than two years.

The Government has agreed that regulatory amendments should be drafted to extend the transition arrangements for certain medical device reforms to 1 July 2029.

Stay updated about the commencement of MDMA and psilocybin for the treatment of certain mental illnesses.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the latest Therapeutic Goods (Permissible Ingredients) Determination.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Understand the Medicines Safety Update for June 2023 - Information for health professionals and consumers.

To help sponsors and manufacturers transition to new manufacturer evidence.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1) for use as a booster dose in adults 18 years and over.

The TGA has issued three infringement notices totalling $39,960 to Queensland-based company Pracmed Healthcare Pty Ltd for alleged unlawful advertising of complementary medicines.

The TGA has issued 38 infringement notices totalling $588,840 to four Sydney-based entities for allegedly importing 22 consignments containing a total of 379,600 nicotine vaping products.

The TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products.

Check the labels of all medicines and medical devices, including those you buy without a doctor’s prescription.

Medicines Safety Update - Information for health professionals

These international recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, are part of a new international recognition framework for medicines that is specific to the UK following their exit from the European Union.

Want to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.

Information about the TGA's safety monitoring of COVID-19 vaccines.

A warning about anticoagulant-related nephropathy (ARN) has been added to the Product Information (PI) for all oral anticoagulants.

Influenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza is given every year.

The TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.

It is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.

Transition period for accepting ISO 13485 ends 26 May 2023.

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989