The TGA has released a Public Consultation and invitation to comment on Proposed amendments to the Poisons Standard, closing Wednesday 17 May 2023, including a proposal for low levels of amygdalin and hydrocyanic acid
Professor John Skerritt, a highly regarded figure in the Australian healthcare sector, recently announced his retirement from the Therapeutic Goods Administration (TGA). Wishing Professor John Skerritt the healthiest retirement! During his tenure as
The TGA has published the outcomes of the public consultation, which closed on 7 November 2022, that sought views on TGA proposed options to allow references to the TGA in therapeutic goods
The TGA has published the outcomes of the public consultation, which closed on 19 December, that sought views on whether the required dual-naming of certain ingredients should end on 30 April 2023.
This technical alert provides members with an update on nitrosamines, including updated information and resources on nitrosamine impurities in medicines from the TGA, and a recent EFSA opinion of nitrosamines in food. Please read
Below are the TGA FOI Checklist documents for further Committee review and discussion. Documents were received by CMA on 16 March 2023. NOTE: These links only work for logged-in Regulatory Committee members.The
Paragraph 47E(d): Documents that would have a substantial adverse effect on the proper and efficient conduct of the operations of an agency20. A document is conditionally exempt under paragraph 47E(d) of the
16. Under subsection 22(1) of the FOI Act, irrelevant information has been redacted from Documents 1-14 as it is considered to be outside the scope of your request. Subsection 22(1): Documents containing
The TGA has published an updated web page on Guidance on applying the Advertsising Code rules. The web page provides temporary guidance in Word and PDF format while the TGA website is
The TGA has published a web page outlining new priority areas for compliance education activities relating to advertising of therapeutic goods for 2023, in alignment with the Import, Advertsising and Supply Compliance priorities 2022-23. The
Further to CMA’s 20 February tech alert, which provided a summary of changes to the Permissible Ingredients Determination (No. 1 of 2023), this technical alert provides members with a comparison table of
A new Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023 commences on Wednesday 1 March 2023. This Technical Alert contains a summary of new, deleted and changed ingredients. A comparison table of all changes to the Determination
The TGA has published a Notice of Interim Decisions in relation to green tea extract and melatonin. The consultation on these interim decisions is open now, closing Friday 3 March 2023. The Delegate
The TGA has published a new document on their website outlining the Mandatory Requirements to vary the Permissible Ingredients Determination. The publication of the document coincides with the publication of the new Therapeutic Goods
The TGA has published an updated web page on Guidance on using evaluation reports from Comparable Overseas Bodies (COB). The changes to this guidance affect eligible: – New substance (or changed substance) applications
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