European Medicines Agency. Guideline on registry-based studies. Committee for Human Medicinal Products (CHMP). EMA/426390/2021

Published by European Medicines Agency

Real World EvidenceReal Word DataRegistry-Based StudyFeasibility AnalysisHuman Medicinal ProductsPatient Registry

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

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