TGA moves AstraZeneca's vaccine on first step toward approval

Regulatory NewsRegulatory News | 09 October 2020 |  By 

The Australian Therapeutic Good Administration (TGA) has taken the first step toward provisional approval of the vaccine against COVID-19 being developed by AstraZeneca in collaboration with the University of Oxford. The decision was made after reviewing the firm’s clinical trial plan and weighing the threats of the pandemic, said TGA in announcing its decision.
On 9 October, TGA gave AstraZeneca’s recombinant chimpanzee adenovirus vector vaccine, ChAd0x1-S, a provisional determination. This first step means that AstraZeneca can now apply for provisional registration in the Australian Register of Therapeutic Goods.
The Australian provisional approval pathway allows drugs or vaccines to enter the market with “preliminary clinical data,” without the submission of a comprehensive data package, while still allowing for transparency and a formal review process, said the regulator.
“Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG,” said TGA.
The agency also noted that it is continuing international collaboration around the development, licensing, distribution, and postmarket evaluation of vaccines for SARS-CoV-2, the virus that causes the novel coronavirus. “The ability to access early data and planned collaboration with international regulators will assist the TGA to expedite the evaluation of any new vaccines without compromising on our strict requirements for safety, quality and effectiveness of products,” said TGA.


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