Major Updates to New (or Changed) Substance Applications: Mandatory requirements to vary the Permissible Ingredients Determination 

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 (Permissible Ingredients – Information that Must Accompany Application for Variation) Determination 2023 on the Federal Register of Legislation (FRL), commencing 1 February 2023.

This means from today, 1 February 2023, there will be an updated process for making applications for a new (or changed) substance in the Permissible Ingredients Determination, including mandatory dossier requirements and data requirements (or justifications for not holding the data) in order to pass the preliminary assessment phase and proceed to the evaluation phase. The changes are an outcome of MMDR changes made to the Therapeutic Goods Act in 2018, and aim to standardise and improve efficiency of the application process. Existing applications will not be affected by the changes.

Compositional Guideline Templates: Four new templates are provided for specific types of substances.

NEW Guidance for Microorganisms (Probiotics and Postbiotics)

Additional guidance on the pre-market assessment of characterising microorganisms that are proposed to be used in either Listed medicines or Registered medicines that are to be used as probiotics and postbiotics. It is to be used in conjunction with the Mandatory requirements for an effective application to vary the Permissible Ingredients Determination (new substance application), or Mandatory requirements for an effective registered complementary medicine application.

The scope of the guidance covers microorganisms are whole and intact cells of bacteria and fungi (including yeasts) that are live or non-viable, but not other kinds of postbiotics, spores, etc.

Please read today’s full alert for more information, background and how to contact CMA if challenges are encountered or changes needed. 

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