The TGA has introduced changes regarding the evaluation of new ingredients to be used in Listed (AUST L) and Listed Assessed (AUST L (A)) medicines.
These medicines may only contain ingredients included in the Therapeutic Goods (Permissible Ingredients) Determination. The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD of the Therapeutic Goods Act 1989 and accompanying guidelines. These came into effect on 1 February 2023 and only apply to new applications submitted from this date.
The IN1 new substance application category has been amended, which means…
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