Information about the Raw Data Proof-of-Concept Pilot for Industry

12 July 2022 — EMA announced the availability of access to raw data for marketing authorization and post-authorization applications submitted to the EMA.

The purpose of this document is to provide an overview about the proof-of-concept (PoC) pilot on the submission and analysis of ‘raw data’ from clinical studies as part of selected initial marketing authorization applications (iMAAs) and post-authorization applications submitted to the EMA.

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