Tech Alert: New mandatory requirements and guidelines documents 

The TGA has published a web page announcing changes to applying for the evaluation of a new substance. The changes apply to all complementary medicines and substances in listed medicines, and include new sections specifically for microorganisms (such as probiotics).

Mandatory requirements for applications to vary the Permissible Ingredients and accompanying guidelines are intended to come into effect in January 2023. This means that from that date, there will be a new way to apply for evaluation of a new substance for use in listed medicines.

CMA has a copy of the suite of new draft documents that have been provided to certain committees, and which we may also provide to requesting members to help prepare any applications for 2023 until the new documents are published in full: Please contact for a copy of the documents. We also welcome urgent feedback on these documents by late November or early December if you perceive there are any parts that cause a significant problem for certain ingredient types. 

Please read todays full technical alert for more information, including a summary of changes to new mandatory requirements and guidelines documents; details of CMA’s engagement with the TGA in the development of these documents; and a 19 page Annex de



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