COVID-19: New Anvisa procedure should speed up vaccine registration
The rule only applies to vaccines to be registered in the country
Published in 18/11/2020 - 14:59 By Andreia Verdélio - Brasília
Brazil’s national sanitary regulator Anvisa has set forth the procedures for the continuous submission of technical data for the registration of vaccines against COVID-19. Now a norm, the decision was approved Tuesday (Nov. 17) by the agency directors.
Directors are also said to have dismissed the regulatory impact assessment and public consultation for the registration due to the urgency of the vaccine and the severity of the disease.
“The measure will allow us to speed up the process of making vaccines against the novel coronavirus available to Brazilians—provided their quality, safety, and efficiency are proved and the technical and regulatory requirement in effect met,” the agency stated in a note.
As part of the continuous submission procedure, the technical data should be sent to Anvisa as they are generated. Thus, companies interested in registering vaccines will not have to have all documents at the ready to present them to the regulating agency.
This procedure is being normalized only for vaccines against COVID-19 to be registered in the country. Other major regulating authorities, Anvisa declared, in the US, Europe, and China, already use this method in specific situations.
Anvisa’s proposal includes meeting two criteria for the use of this special procedure. One of them concerns the demand of a clinical drug development file on the vaccine submitted, with its protocol complete at the agency. Another criterion is that the research must be in its phase 3 of clinical development.
Translation: Fabrício Ferreira - Edition: Kleber Sampaio / Nira Foster
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