Metadata list describing real-world data published on the EMA website

A list of metadata describing real-world data sources and studies has been publish on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

Following extensive consultation with stakeholders, including ENCePP members, the chosen metadata will be included in a catalogue of data sources containing information about existing real-world databases (to replace the current ENCePP catalogue) and information about the studies performed on the data sources (to replace and enhance the current EU PAS Register). Setting up a catalogue of data sources and enhancing the catalogue of studies aims to improve transparency with regard to observational studies, enhanced discoverability of studies and data sources, and contribute to increasing the ability to judge the evidentiary value of studies when used to investigate the use, safety and effectiveness of medicinal products.

Related information: HMA/EMA Big Data Steering Group