Inclusion and Exclusion Criteria

This review was mainly prepared by extracting data from EPARs. We included systemic antibacterial substances that were authorized by the EMA without any time restriction. The EMA website was screened applying the following filters [29]:

“Human” AND “European public assessment reports (EPAR)” AND “Authorised” AND “antibacterials in systemic use”;

“Human” AND “European public assessment reports (EPAR)” AND “Authorised” AND “antimycobacterials”.

Furthermore, antibiotics approved by the FDA since 2017 but not yet by the EMA were included. Therefore, the Centerwatch website was screened for “FDA approved drugs” in the area “Infections and Infectious Diseases” [30]. Only systemic antibacterial substances were selected. The relevant reviews were taken from the FDA access data website [31]. The last revision of the websites was on 3 October, 2019. The FDA-approved antibiotics were added as the EMA will potentially authorize them within the next months or years. The last three EMA-approved antibacterial drugs were all previously accepted by the FDA [32]. On 4 October, 2019, the EMA published the monthly update of applications for new human medicines and it listed all five FDA-approved antibiotics included in this review [33].

Generics and hybrid medicines were excluded because they do not undergo the same authorization process as a novel drug. Missing information in the EPARs was completed, if original publications were found on PubMed and could be identified as the source that the EPAR was referring to with high likelihood. Additionally, we used information from FDA authorization reviews to fill gaps.