The objective of this Guideline is to provide recommendations on key methodological aspects that are
specific to the use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs)
planning to conduct registry-based studies
European Medicines Agency. Guideline on registry-based studies. Committee for Human Medicinal Products (CHMP). EMA/426390/2021
Published by European Medicines Agency
Patient RegistryReal World EvidenceReal Word DataRegistry-Based StudyFeasibility AnalysisHuman Medicinal Products