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COVID-19 vaccine approval process
Understand the regulatory process of how a COVID-19 vaccine application is submitted and assessed before the vaccine is approved for supply in Australia.
The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 vaccines before they can be used in Australia. We will only register a vaccine if its benefits are much greater than its risks.
This page provides an overview of the vaccine approval process using the provisional approval pathway, which is the pathway being used by pharmaceutical companies to date.
Stage 1: Pre-application
In order to submit an application under the provisional pathway, a sponsor (usually a pharmaceutical company) must first submit a provisional determination application.
The TGA will assess the application against specific eligibility criteria, such as the nature of preliminary clinical data, evidence of a plan to submit comprehensive clinical data, and the clinical need.
If the TGA grants provisional determination, the sponsor is then eligible to apply for provisional registration of the vaccine in the Australian Register of Therapeutic Goods (ARTG).
Importantly, granting provisional determination does not mean that the sponsor will submit an application, or that the TGA will approve the subsequent application.
Stage 2: Application
Once provisional determination has been granted, the sponsor then needs to submit an application for provisional registration in the 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.
Stage 3: Evaluation
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.
Stage 4: Decision
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:
- the safety, quality and effectiveness of the vaccine has been satisfactorily established for its intended use
- the sponsor's plan to submit comprehensive clinical data, stability data and other information before the provisional registration ends.
Stage 5: Registration
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.
Approved vaccines will appear in the searchable ARTG on the TGA website. Product Information and Consumer Medicines Information will also be available on the TGA website in the same way as for any other registered medicine.
The provisional registration is for an initial period of two years, with the option to apply for up to two extensions, up to a maximum of six years.
Stage 6: Monitoring
The TGA will continue to play an active role in the ongoing monitoring of any vaccines available in Australia, and has robust procedures in place to investigate any potential new safety issues.
The TGA's vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.
The post-market monitoring relies on reviewing and analysing adverse events reports, working with international regulators and reviewing medical literature, media and other potential sources of new safety information.
Weekly safety reports can be accessed through the Communicating COVID-19 Safety information.
After the initial registration of a vaccine, the sponsor may request changes to the registration details, which require additional assessment and approval by the TGA.