Diarmuid Waide, Regulatory Product Specialist here at Ennov, gives us a behind-the-scenes look at the EMA’s eCTD 4.0 pilot and what it revealed about the gap between theory and real-world readiness.

• Track key implementation deadlines: Explore the updated eCTD 4.0 timeline
• Know what’s changing and why it matters: Read the readiness guide
• Get everything in one place: Visit the eCTD 4.0 resource hub