The PoC pilot is performed to investigate the benefits of having access to raw data from regulatory submissions to support the scientific assessment of medicinal products and to identify the associated operational, resource and technological needs.
Learnings from the PoC pilot will be systematically collected and evaluated. This will include asking for feedback from the Rapporteurs’ assessment team,
the Agency, and the applicant or marketing authorisation holder (MAH) of the regulatory procedures concerned by the PoC pilot phase.
The ultimate aim of the pilot is to generate learnings that will be translated into recommendations to the European Medicines Regulatory Network on the future role of access to raw data to support the regulatory assessment.
Questions and Answers about the raw data proof-ofconcept pilot for industry