TGA New Substance Evaluation

Jun 6, 2023

The Therapeutic Goods Administration (TGA) is responsible for evaluating new substances for use in Listed therapeutic products in Australia. The evaluation process typically involves the following steps:

  1. Pre-submission phase -The first phase includes applying for new substance name, a pre-submission meeting and dossier presentation. The dossier must meet or provide justification for not meeting the Mandatory Requirements to pass the preliminary assessment.
  2. Application submission: The sponsor of the new substance must submit an application to the TGA, including information on the substance’s identity, quality, safety, and efficacy.
  3. Preliminary assessment: The TGA conducts a preliminary assessment of the application to determine if it meets the basic requirements for evaluation. If the application is deemed acceptable, the TGA will assign a reference number and initiate the evaluation process.
  4. Evaluation: The TGA evaluates the safety, quality, and efficacy of the new substance using a variety of scientific and regulatory criteria. This may involve consultation with other regulatory agencies, experts in the relevant field, and the public.
  5. Decision-making: Based on the evaluation, the TGA will make a decision on whether to approve the new substance for use in therapeutic products in Australia. The decision may be to approve with conditions, reject, or request additional information.
  6. Post-approval monitoring: Once a new substance is approved, the TGA continues to monitor its safety and efficacy through ongoing surveillance and post-market reporting requirements.

The TGA’s evaluation process is designed to ensure that new substances used in therapeutic products are safe, effective, and of high quality. The process can be lengthy and rigorous, but it is critical for protecting the health and wellbeing of Australians who use these products.

For further information please refer to here or contact DTS.