Snapshot

The COVID-19 vaccine approval process pathway has been developed by the of Australia.

This pathway can be used where COVID-19 vaccines.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Once provisional determination has been granted, the sponsor then needs to submit an application for provisional registration in the Australian Register of Therapeutic Goods (ARTG). To register a COVID-19 vaccine in Australia, a sponsor is required to submit a comprehensive dossier that includes specific information on clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information. The TGA may agree upfront to accept a limited number of rolling submissions of data during the evaluation phases, as well as reports from comparable overseas regulators. The TGA will make a preliminary assessment whether to accept the submission for evaluation and will notify the sponsor. Once an application is accepted, the TGA will commence a formal evaluation process that is carried out in multiple phases by technical experts. This process involves obtaining further information and clarification from the sponsor, as well as being informed by the advice of the Advisory Committee on Vaccines, an independent committee of external experts. Once the evaluation is complete, the TGA delegate will make a decision whether to provisionally register the vaccine in the ARTG. The decision to approve a new vaccine is always made by the TGA on the basis that the benefits outweigh the risks. The TGA delegate's decision to grant provisional registration is based on a number of factors including: (i) the safety, quality and effectiveness of the vaccine has been satisfactorily established for its intended use, (ii) the sponsor's plan to submit comprehensive clinical data, stability data and other information before the provisional registration ends. Once approved by the TGA, the vaccine is included in the ARTG as a provisionally registered medicine and is able to be lawfully supplied in Australia by the sponsor. The provisional registration process is designed with a target timeframe of 220 working days from acceptance for evaluation through to the delegate's decision. The statutory timeframe for provisional registration is 255 working days (regulation 16C(3)). To facilitate earlier access to vital medicines, provisional registration applications will be prioritised within the target timeframe.