HTTPS support for EMA E2B(R3) reporting
Summary
EMA Phasing out HTTP URLS to use HTTPS for E2B(R3) reporting (Enhancement 38561645)
Description
EMA has announced that HTTP access to schemas will be phased out by April 2026 due to security concerns. To align with this directive, this release introduces support for HTTPS schema references for the following profiles:
- ICH-ICSR V3.0 MESSAGE TEMPLATE – EMA
- ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE – EMA
- E2B R3+ (Safety One Intake profile, applies only to Safety One Argus)
Custom profiles created from these factory profiles will also reference HTTPS, ensuring secure data transmission and compliance with EMA requirements. There is no impact on the reports that are already transmitted before upgrade.
Parent topic: Regulatory enhancements