TGA Marketing Authorization Application

TGA Marketing Authorization Application

The Health Authority for Australia. Therapeutic Goods Administration (TGA), has distinct registration categories for different types of pharmaceutical products that want to enter the Australian Register of Therapeutic Goods (ARTG). To achieve a successful submission and approval. It is critical to have experience in handling the Marketing Authorization Application (MAA) submission for pharmaceutical products to TGA. Therefore, it is essential to have expertise in meeting the typical requirements of TGA in the MAA to ensure a smooth review and approval process of the application. Without adequate data, the approval process may experience a delay. Subsequently leading to a delay in the market entry of the product.

As a proven regulatory partner, Templarpharma assists pharmaceutical manufacturers/MAA holders in managing legal and administrative requirements while communicating with TGA. Freyr provides registration support. Enabling MAA holders and manufacturers to access the Australian market with the registration and distribution of their pharmaceutical products.

Freyr’s in-depth understanding of TGA requirements/practices, coupled with extensive experience in handling multiple MAA applications for the TGA, enables it to provide various services to MAA holders.

Templarpharma Expertise in TGA Marketing Authorization

  • Templarpharma can provide guidance on the regulatory submission roadmap to identify the application category type.
  • As a legal office and contact point in Australia, they can manage communications with the TGA for registration and follow-up for approvals. Templarpharma can also support interactions with the TGA on scientific aspects.
  • Templarpharma can provide guidance in the selection of test product and reference medicinal product bio-batch lot for bioequivalence study. They can also provide support in the selection of dissolution parameters/multimedia for the performance of dissolution for the test product and reference medicinal product (RMP).
  • Templarpharma can support the preparation of a product development report, highlighting the discriminatory nature of media. They can also finalize the specifications for finished products. In-process/intermediates, and review protocols/reports for exhibit batches/stability study.
  • Templarpharma can conduct technical gap-analysis of source documents/data for adequacy against TGA specific requirements. Additionally, they can compile, technically review, finalize, publish, and submit TGA Marketing Authorization application in the eCTD format.
  • In the event of TGA queries. Templarpharma can handle them with strategies and prepare response packages for submission of marketing authorization approval.