Applications using the new variation classification forms must not be submitted before 15 January 2026, otherwise they will be rejected and require resubmission.

EMA will host a dedicated Q&A clinic on 8 January 2026 to answer questions regarding eAF functionality changes related to the revised variation classification guideline.

Applicants are reminded that all PLM Portal-generated eAFs must include the corresponding FHIR XML attachment when submitted to health authorities.

From 22 December 2025, applicants may optionally submit new CAP Marketing Authorisation Applications using eCTD v4.0 while eCTD v3.2.2 remains accepted.

Release notes for version 1.2.1.2 describe bug fixes and updates implemented in the December 2025 production release.

CGTDG - Recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines The Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided as an output of its 2-year remit, Recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines.

The Cell and Gene Therapy Discussion Group, which was established in May 2023, has just published its recommendations paper, Recommendations with Regard to Future Advanced Therapy Medicinal Products-related Guidelines.

The Q&A document has been expanded with questions collected during 2025 webinars and support sessions to help applicants use the PLM Portal eAF more effectively.

EMA announced plans to launch a Phase III eCTD v4.0 forward compatibility pilot and encouraged vendors to prepare their tools for participation.

EMA invited stakeholders to review and provide feedback on the draft version 1.1 validation criteria before final publication.