The European Medicines Agency (EMA) has announced its ongoing efforts to further improve the efficiency of the assessment and approval processes for new medicinal products within the European Union (EU). This initiative aims to optimize the utilization of the regulatory network's expert resources, streamline assessment procedures, and encourage applicants to submit more comprehensive application dossiers from the outset. A critical area identified for improvement is the reliability of long-term planning for initial marketing authorization applications (MAAs), as only 35 % of MAAs were submitted on time in 2023.

To address these challenges, EMA and the Heads of Medicines Agencies (HMA) are implementing comprehensive measures, including reinforced best practices for clock-stop extensions, revised assessment templates, and enhanced guidance for assessors. Additional initiatives include improving the predictability of post-marketing activities and fostering closer dialogue with applicants. EMA plans to pilot automatic notifications to marketing authorization holders about planned submissions and will launch a project in 2025 aimed at enhancing pre-submission interactions. This collaborative approach aims to address issues related to premature data submissions and improve submission predictability through better communication between applicants and regulatory authorities, ultimately expediting the availability of safe and effective treatments for patients.

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