New Summary of fees and charges to applications submitted to the TGA

We are pleased to inform you that the Therapeutic Goods Administration (TGA) has implemented a significant update to its fees, which came into effect on July 1, 2024. This update is part of the TGA’s ongoing commitment to recover the costs associated with regulating therapeutic products and fulfilling the public health responsibilities outlined in the Therapeutic Goods Act of 1989.

Here are some key points about these changes:

📈 Service Fees: The TGA will charge specific fees for services rendered, including the evaluation of products. These charges are considered a form of industry tax and are applied annually, aligned with the Australian financial year (July 1 to June 30).

📋 Fee Summary: The updated guide provides a summary of the fees and charges applicable to submissions made to the TGA. For a complete and detailed list of all fees and charges, as well as the exact legislative text, it is recommended to consult the Australian legislation on therapeutic goods directly.

🔗 For more details, please review the TGA Fees and Charges Guide and stay informed about how these changes may impact your operations and strategies.

This adjustment reflects the TGA’s effort to maintain efficiency and transparency in the regulation of therapeutic products, while ensuring adequate cost recovery.

Thank you for your attention and for your continued commitment to regulatory compliance.