BioLineRx(BLRX) - 2023 Q4 - Annual Report

Marketing Applications (NDAs and BLAs) Post-Marketing Requirements Expedited Programs for Serious Conditions Within the European Union (EU) and the European Economic Area (EEA), which is composed of the 27 member states of the EU plus Norway, Iceland and Liechtenstein, the authorization of clinical trials occurs at member state level. The European Medicines Agency, or EMA, plays a key role in ensuring that GCP standards are applied across the European Economic Area, or EEA in cooperation with the member sta ...