This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data6 in clinical studies  to support a regulatory decision on effectiveness or safety of a drug.

This report builds on the experience previously acquired during the period from September 2021 to February 2023 in conducting regulatory-led studies using real-world data (RWD) to support EU regulatory decisions

The European strategy for data 1 proposed the establishment of domain-specific common European data spaces. The European Health Data Space (‘EHDS’) is the first proposal of such domain-specific common European data spaces.