https://www.ema.europa.eu/en/human-regulatory/marketing-au...

EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:

• the benefit-risk balance of the medicine is positive; - для детей условие не выполнено
• it is likely that the applicant will be able to provide comprehensive data post-authorisation;
• the medicine fulfils an unmet medical need; - при наличии эффективного лечения и профилактики (ивермектин в профилактике показал эффективность 89-98%) не выполнено
• the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.

И FDA: FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.

Доказательная медицина, COVID-19, ЗОЖ