The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination (‘the Permissible Ingredients Determination’).
On 1 February 2023, mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD of the Therapeutic Goods Act 1989, and accompanying guidelines came into effect (read more about Changes applying to evaluation of new substances for listed medicines). These describe the data expectations for any new ingredient application for listed therapeutic goods, including new ingredients for use on the skin (such as sunscreen ingredients)…
