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

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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