New EMA Services to improve quality of submissions and help ensure validation

Pre-authorisation

  • ​A list of validation issues seen with initial MAAs is now available on the EMA website; it is aimed at facilitating the preparation of dossiers and covers all five CTD modules.

Post-authorisation

  • A list of validation issues seen with initial MAAs is now available on the EMA website; it is aimed at facilitating the preparation of dossiers and covers all five CTD modules.
  • The EMA has recently introduced a Pre-submission queries service for various post-authorisation submissions including Variations, MAH transfers & PASS; advice can be provided by an EMA Procedure Manager to facilitate validation of these procedures.
  • Q and A on this pre-submission service were updated on the EMA website in December 2017.
  • Pre-submission checklists for Variations, Renewals and Annual Re-assessments are now available to help applicants to avoid the frequent mistakes that prevent validation of these applications.

These new services were highlighted during the monthly regulatory intelligence review conducted by EUDRAC for all countries worldwide. EUDRAC provides specific regulatory intelligence updates to clients tailored to their regulatory and marketing needs.