EMA released validation checklist for initial MAA of the Centralised Procedure (CP)

EMA released validation checklist

EMA released validation checklist for initial MAA of the Centralised Procedure (CP)

Currently, validation issues occur in 90% of initial marketing authorisation applications (MAAs).  These validation issues create additional workload for companies and potential delays at a critical moment for the timely start of the procedure.

To make the validation process more efficient, predictable and easier to navigate, EMA has release a new validation checklist.

EMA is encouraging applicants to submit this new validation checklist as part of the MAA dossier.

If you are planning a Centralised Procedure and would like to have support, please contact us at [email protected]

Asphalion has extensive experience with Centralised Procedures.

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