High-end COVID-19 vaccine gets admission ticket to EUA in Australia-Life-Free Times Electronic News



High-end COVID-19 vaccine, get admission tickets to the Australian EUA. (Data photo)

2021/11/22 14:37

[Reporter Chen Yongji/Taipei Report]The Australian Drug Administration (Therapeutic Goods Administration, TGA) announced today (22) that after comprehensive consideration of vaccine information and the severity of the epidemic, it has decided to grant Taiwan’s high-end COVID-19 vaccine “examination qualification” “(Provisional determination). High-end said that this qualification is a key step in applying for an Australian vaccine emergency use license (provisional approval is similar to EUA), which means that high-end COVID-19 vaccines can use this qualification to speed up the review process of Australia’s inspection and registration.

Gao said that it has started to prepare the application documents and will formally apply to the TGA for emergency vaccine approval as soon as possible, hoping to speed up the acquisition of international certification. As for how long it will take for the TGA to review, it is currently unknown.

In response to the COVID-19 epidemic, Australia’s TGA has successively granted review qualifications to AZ, Pfizer, Modena, Johnson & Johnson and Novavax. A total of 5 vaccine factories have undergone accelerated review. Taiwan’s high-end COVID-19 vaccine is currently the sixth to obtain COVID-19 vaccine certified by TGA.

Gao said that according to TGA’s regulations on COVID-19 vaccines, whether it is the first time to apply for an emergency vaccine license or to expand the age of the population after the vaccine is marketed, the review process must be verified through qualification verification.

High-end pointed out that Australia’s TGA is highly credible among the global medical regulatory authorities. It is not only one of the 36 Stringent Regulatory Authorities defined by the World Health Organization, but also one of the top ten advanced medical countries recognized by my country’s inspection and registration regulations. Certification unit. In the process of formulating international medical regulations related to COVID-19, Australia’s TGA is also a participating member of the “ICMRA International Drug Regulatory Authority Alliance”, the “Access Consortium Alliance”, and the “European Union COVID-19 Vaccine and Therapy Committee”. .

Australia TGA announcement link

https://www.tga.gov.au/node/941531

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