Australia: Guidelines Update for Sunscreens by TGA

The Therapeutic Goods Administration (TGA) released updates for sunscreen regulatory guidelines in line with the proposed data requirement that is to be included under the Permissible Ingredients Determination. Previously on 1 February 2023, TGA enforced mandatory requirements under Section 26BD of the Therapeutic Goods Act 1989 for any applications to vary the Permissible Ingredients Determination together with the guidelines.

The guidelines brief the data requirements for new ingredient applications for listed therapeutic goods and skin use. Then, TGA inspects and evaluates the quality and safety of all the ingredients to be on the standard par. Any applications will be evaluated based on the current guidelines. Hence, the manufacturers are advised to keep up to date with guidelines updates.

-Updates on Australian Regulations Guidelines for Sunscreen (Version 3.0)

• Two tables are provided in Part B for details regarding information on the quality or safety of the new sunscreen ingredient.

• ARGS allows evidence statements to be included in the dossier if no core information can be provided.

• Including guidance on how to reduce TGA’s de novo evaluation via Comparable Overseas Bodies (COB) process.

• Including guidance on how to apply for 2 years exclusivity period for new ingredients.

• Removal of sun protection factor testing details and only follow International Organization for Standardization (ISO) methods.

Sources: TGA

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