Administrator EU eCTD v4.0 vs v3.2.2: What Changes on 15 July 2026 EMA's refreshed validation criteria take effect this July, aligning the validator with the dual-version eCTD reality. Here's what applicants need to prepare for. Jul 3, 2026
Administrator eCTD Validation Rules: Why Submissions Get Refused to File Broken hyperlinks, XML backbone errors, and incorrect sequencing are the most common causes of a Refuse to File notice. A look at how to avoid them. Jul 3, 2026
Administrator AS2 Gateway vs Web Client: Choosing Your EMA Submission Channel Gateway, Web Client, or CESP? A practical breakdown of which submission channel fits centralized, decentralized, and mutual recognition procedures. Jul 3, 2026
Administrator PMDA Mandates eCTD v4.0 — Is EMA Next? Japan became the first ICH region to require eCTD v4.0 in April 2026. What that means for EMA's own timeline. Jul 3, 2026