Anvisa reduces requirements and simplifies the registration of vaccines against Covid-19

Anvisa reduces requirements and simplifies the registration of vaccines against Covid-19

National Health Surveillance Agency (Anvisa) published a technical note this Tuesday (29). After the admission of the new product protocol, the team will analyze documentation within 20 days.

Voluntário recebe teste de vacina contra a Covid-19 na Flórida em 24 de setembro — Foto: Marco Bello/Reuters

The National Health Surveillance Agency (Anvisa) published a technical note on Tuesday (29) that reduces the initial documentation and simplifies the registration for vaccines of Covid-19. The name of the procedure is “continuous submission”.

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The measure, exclusively for the registration of immunizers against the new coronavirus, was taken to “make data analysis faster”, according to Anvisa. The interested company or institution must enter a protocol with the regulator, but without the need for all technical documents and requirements at the beginning of the process.

[huge_it_slider id=”15″]With the project in hand, Anvisa established a period of up to 20 days to respond to the interested pharmacist or institution. During the period, the regulator will communicate any pending issues and information to be presented and, thus, speed up the process. “The continuous submission procedure does not affect the required quality standard in any way”, explains the agency.

“The strategy aims to speed up the availability to the Brazilian population of vaccines against the new coronavirus, as long as quality, safety and efficacy are guaranteed”.

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