EMA launches checklist to facilitate validation for initial marketing authorisation applications

February 8, 2019 – A survey launched by EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications (MAAs). They 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 is encouraging applicants to submit a new validation checklist as part of the MAA dossier … (leggi tutto)