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).
The TGA evaluates the quality and safety of all substances to the same standard before they can be included in the Permissible Ingredients Determination. As such, the quality and safety data requirements have been updated in the ARGS version 3.0 to align with the requirements for all new substances for use in topical listed medicines described in the Application requirements for new substances in listed medicines (ARNS) published on 1 February 2023.
Any existing applications that are currently under TGA evaluation will continue to be evaluated in line with the guidance existing at the time the application was submitted. Any new applications submitted after the ARGS version 3.0 was published will be evaluated in line with this guidance.
The main change in the ARGS version 3.0 is to Part B of the guidance which describes how to apply for a new sunscreen ingredient. Part B now includes two tables (Table 3 and 4) describing what core information is expected to establish quality or safety of a new sunscreen ingredient. These tables are an excerpt from the ARNS published on 1 February 2023.
The ARGS also describes that in circumstances where data or information cannot be provided to address a core information requirement, for example where particular tests are not feasible, appropriate or necessary, then a justification for not including this in the dossier is to be provided.
Other changes in the ARGS provide guidance for how the TGA's de novo evaluation may be reduced by using the Comparable Overseas Bodies (COB) process; and how applicants can request to have a eligible new ingredient protected for a 2 year exclusivity period once approved.
Details of sun protection factor (SPF) testing have been removed and updated to follow the International Organisation for Standardisation (ISO) testing methods.
The list of active sunscreen ingredients in Table 7 has been updated to reflect the current Permissible Ingredients Determination, and the Glossary of terms and abbreviations have also been updated with new terms such as 'ARNS'.
Other editorial and minor changes to overall text to remove repetitive information and update links to current documents have also been made.
Background
All listed therapeutic sunscreens (sunscreens that carry an AUST L number on the label) may only contain ingredients included in the Permissible Ingredients Determination.
For a substance to be permitted for use as an ingredient in listed medicines, an application must first be submitted to the TGA. The TGA will evaluate the substance to determine whether it is of appropriate safety and quality to be permitted for use as an ingredient in listed (low risk) therapeutic goods. Once the substance is determined to be safe, it is included in the Permissible Ingredients Determination.
Further information
If you have any further questions, please contact Complementary Medicines via phone on 1800 020 653 or via email at [email protected].
