Snapshot

The Temporary authorization for emergency use of medication for COVID-19 pathway has been developed by the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil.

This pathway can be used where All drug products meant to address the COVID-19 pandemic..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Argentina Australia Canada China EU-EMA India Japan Russia South Korea United Kingdom United States

7 or 30 days. 7 days: when clinical development of the drug is taking place in Brazil or when the technical opinion issued by a recognized national medicines regulatory authority proves the quality, safety and efficacy standard established by WHO/ICH/PICs. 30 days: If neither of the conditions mentioned above are applicable. In both cases review will take longer if supplemental information is requested by ANIVA, how much longer is not stated.