COVID-19 treatments: Article 18 and Article 5(3) reviews
The European Medicines Agency (EMA) may review COVID-19 medicines under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).
This is intended to support national decision-making on the possible use of these medicines before a formal authorisation is issued.
During an Article 18 review, EMA's Emergency Task Force (ETF) reviews the available data on the use of the medicine and submits this to the Committee for Medicinal Products for Human Use (CHMP) for an opinion.
Article 18 reviews of COVID-19 medicines replaced those previously conducted under Article 5 (3) of Regulation establishing EMA (Regulation (EC) No 726/2004) when the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) took effect in March 2022.
EMA's ETF is reviewing the available data on the use of the following medicines to treat certain patients with COVID-19, under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123):
|Treatment||Key milestones||More information|
|Sabizabulin||Start of review under Article 18: 27/07/2022||EMA reviewing data on sabizabulin for COVID-19|
For more information on Article 5(3) evaluations, see: