Articles

This instrument is made under section 39 of the current Poisons Standard.

We are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine and Pharmacist Only medicine products.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.

This instrument is made under section 39 of the current Poisons Standard.

Summary of Changes made to transition eCTD AU Module-1 v3.1 to eCTD AU Module-1 v3.2

This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

This instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.

This instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.

Find out about our position on Messenger RNA (mRNA) technology.

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.

Six monthly report – supply of unapproved therapeutic goods by a sponsor.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.

This instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Approval 2024.

Voluntary cancellation of AstraZeneca COVID-19 vaccine: Vaxzevria

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.

The TGA and Health Canada have signed a Memorandum of Understanding to further increase collaboration and reliance on Good Manufacturing Practice inspections conducted in countries outside each other's borders.

From 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.

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

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

This instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under subsection 19(7D) of the Therapeutic Goods Act 1989.

We have issued a notice to Pracmed Healthcare Pty Ltd to cease advertising indications related to weight loss surgery and cognitive function.

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.