COVID-19 medicines: Article 18 and Article 5(3) reviews

The European Medicines Agency (EMA) may review COVID-19 vaccines and treatments 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 vaccines 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.

    Ongoing reviews for COVID-19 vaccines

    EMA's ETF is currently not reviewing data on any vaccine under under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

    Ongoing reviews for COVID-19 treatments

    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):

    TreatmentKey milestonesMore information
    SabizabulinStart of review under Article 18: 27/07/2022EMA reviewing data on sabizabulin for COVID-19

    Completed reviews for COVID-19 treatments

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