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Vietnam: Cases of exemption from one or more clinical trial phase when applying for marketing authorization

Bảo Ngọc

16:50, 20/08/2021

On August 19, 2021, the Ministry of Health of Vietnam issued Circular 11/2021/TT-BYT stipulating guidance on registration of circulation of Covid-19 vaccines in urgent cases.

According to Vietnam's Circular 11/2021/TT-BYT, for vaccines that have not met the requirements for clinical data to ensure safety and effectiveness in the applications for vaccine marketing authorization, the Minister of Health of Vietnam may consider and decide to exempt vaccines not meeting the requirements from one or more than one clinical trial phase (including clinical data reduction or exemption) based on advice of the advisory board in any of the following cases:

(1) The vaccine has been authorized by at least one country and has clinical data on its safety and effectiveness.

(2) The vaccine is manufactured in Vietnam using transferred technology for one or more than one part of or the whole manufacturing process and, prior to the technology transfer, the vaccine has clinical data on safety and effectiveness and is authorized by at least one country.

Vietnam's Circular 11/2021/TT-BYT takes effect from August 19, 2021 to the end of December 31, 2022.

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