The European Medicines Agency (EMA) focus group on submission predictability monitoring report (H2-25 MAAs pipeline monitoring exercise) makes one thing clear: predictability in Marketing Authorisation Applications (MAA) is improving, but industry still has significant room to mature.
Key findings include:
- 57% of MAAs were submitted on time, up from 48% in 2023.
- Short-notice delays remain a major issue: over 60% of applicants provided less than 60 days’ advance warning before shifting their submission date.
- Justifications for delays are often missing or uninformative; only 73% of applicants who changed their plans provided a justification, and many cited internal resource constraints or planning issues.
- Generics and biosimilars frequently bypass timely Letters of Intent, creating additional unpredictability.
- While communication between applicants and regulators has improved, the overall planning reliability remains insufficient to support efficient workload allocation across the EU regulatory network.
The report concludes that although progress is visible, predictability challenges continue to strain regulatory resources, and further improvements in applicant planning and transparency are essential. EMA will continue monitoring but will shift focus toward new approaches aligned with the upcoming New Pharmaceutical Legislation.
With the regulatory network under increasing workload pressure, companies that invest in predictable, well-governed submission processes will be better positioned for smooth assessments and timely approvals.
If your organisation is preparing an EMA Marketing Authorisation Application for 2026–2027, now is the moment to reinforce planning discipline and operational readiness. At Starodub, we support teams in building predictable, regulator-aligned submission strategies that stand up to scrutiny and reduce avoidable delays.
Get in touch to discuss how we can support your organisation for EMA MAA support, or other compliance or regulatory activities at [email protected] or visit our website at www.Starodub.nl.
