[JAN] Emergency Use Authorization (EUA)

Question 1

When can it be allowed?

Answer 1

It is a ‘Rare Disease’

Massive disease outbreak

No proven vaccine or drug available

Evidence of a drug or vaccine that is tested in a country and has yielded desired results

A country neither has the financial resources nor the personnel to conduct solid clinical trials to a drug/vaccine that has undergone thorough clinical trials in another country

Question 2

under which provisions?

Answer 2

New Drugs and Clinical Trials, 2019 mentions an ‘accelerated approval process’, depending on the severity, urgency and lack of alternatives.