Snapshot

The Emergency Use Authorization of COVID-19 Vaccine pathway has been developed by the Food and Drug Authority of Ethiopia (EFDA) of Ethiopia.

This pathway can be used where This pathway is for the emergency use authorization (EUA) of COVID-19 vaccines. Issuance of an EUA would require a determination by EFDA that the vaccine’s benefits outweigh its risks based on data from at least one well designed phase III clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner. It is the EFDA's expectation that, following submission of an EUA request and issuance of an EUA, a sponsor would continue to collect placebo-controlled data in any ongoing trials for as long as feasible and would also work towards submission of application for normal medicine registration as soon as possible. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Armenia Australia Brazil Canada China EU-EMA Europe Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States

The total target (agency) time for assessment is not stated in the guideline.