Articles

TCMs sold in Australia are carefully regulated to ensure safety and quality.

If your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.

We know that paracetamol is safe and effective for most people when taken at the recommended dose.

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.

‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).

From 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG).

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.

Delays in processing timeframes of applications to extend GMP Clearances.

The TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.

Following a safety investigation into pholcodine the TGA are cancelling 55 products (from the ARTG) and recalling them from pharmacy shelves due to an increased risk of anaphylactic reactions.

Make small changes to how you think about paracetamol.

The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.

Consumers are advised to be cautious about ivermectin products that are sold by unverified online stores.

How to find information about the inactive ingredients in your medicines.

In response to the COVID-19 pandemic, the TGA is implementing Serious Shortage Medicine Substitution Notices

Community pharmacists to enforce new limits on dispensing and sales of prescription and over-the-counter medicines

Information for consumers

Australian launch of a new product called Nyxoid nasal spray for opioid overdoses

For some people, vitamins are an important part of their health.  Learn how the TGA regulates vitamins.