Anvisa, Brazil's National Health Regulatory Agency, on Wednesday presented a new streamlined procedure for registering progress on the development of a novel coronavirus (COVID-19) vaccine, in a bid to speed up its availability.
According to the new rules published in the Government Gazette, the procedure is only valid for COVID-19 vaccines registered in the South American country.
The procedure facilitates the continuous submission of technical data to Anvisa as soon as it is generated, so companies interested in registering their vaccines in Brazil won't have to repeatedly present all the relevant documents to the regulatory body.
The agency also dispensed with the analysis of the effects of the regulation and public consultation for the registry, due to the degree of urgency and the severity of the pandemic.
"The measure will accelerate the availability for the Brazilian population of vaccines against the novel coronavirus, provided that the quality, safety and efficacy are demonstrated in accordance with current technical and regulatory requirements," the agency said in a statement issued earlier. Enditem