Brazilian regulator shortens time to approve vaccine clinical trials

clinical trials vaccine
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Starting this Wednesday, Brazilian health regulator Anvisa will have up to 120 days to analyze requests for clinical trials to produce coronavirus vaccines in the country. Previously, the agency had up to 180 days to carry out assessments. The new rule will remain in effect until 120 days after the Health Ministry has declared the end of the Covid-19 public health emergency.

In Brazil, clinical trials on vaccines can only start once receiving approval from Anvisa and the ethics committees responsible for the field. With the change, the 120 days will begin counting from the date of delivery of the first specific clinical trial dossier. The rule also applies to requests already sent to Anvisa, but which have not yet started analysis.

Regarding coronavirus medications, the health regulator will allow products to be brought to Brazil if they have at least one study approved by accepted foreign regulatory agencies. In these cases, the studies can be carried out as soon as they are given the go-ahead by ethics committees.