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In Brazil, the National Sanitary Inspection Agency (Anvisa) has rejected a request to approve the Russian vaccine against the Sputnik V coronavirus for emergency use.
It was submitted by the pharmaceutical company Uniao Química, but the state regulator returned the documents, stating that the drug from the Russian Federation did not meet the minimum criteria. Anvisa’s press service reports on this.
“The application was returned to the company due to the lack of approval for the third phase clinical trials, as well as issues related to good manufacturing practices,” he said in the message.
The regulator stressed that even a single request for a third phase of vaccine trials is not enough to get approval for use. In particular, it is necessary that such an investigation be carried out in the country.
At the same time, Anvisa clarified that the application for clinical trials must be submitted by the drug developer himself, and the documents must include guarantees of the safety and efficacy of the trials.
As OBOZREVATEL reported:
