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

Published by European Medicines Agency

Registry-Based StudyFeasibility AnalysisHuman Medicinal ProductsPatient RegistryReal World EvidenceReal Word Data

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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