New release notes highlight bug corrections and functional improvements delivered in the January 2026 update.

Three ICH Expert Working Groups have issued an updated document package, a mapping document and training materials, respectively, associated with three technical Guidelines: E2B(R3) - Individual Case Safety Report Specification; M4Q(R2) - The Common Technical Document; and E6(R3) - Good Clinical Practice.

EMA announced new ESMP functionalities, webpage reorganisation, updated FAQs and factsheets to support medicine shortage monitoring and reporting activities.

Updated release notes document bug fixes and enhancements introduced with the latest PLM Portal eAF production release.

Submission processing through AXWAY Gateway will be unavailable during a planned maintenance window on 10 January 2026.

As a follow-up to the November 2025 endorsement and publication of the ICH E22 draft Guideline on General Considerations for Patient Preference Studies, the E22 Expert Working Group has issued an informational presentation and training materials.

eSubmission services including Gateway XML FileHandler and PSUR Repository will undergo scheduled maintenance on 7 January 2026.

Marta Marcelino INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA

Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025