The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025.

In follow up to the publication of the ICH M11 Updated Technical Specification (TS) in March 2025, the M11 EWG has also prepared a Step 2 informational presentation.

Further guidance on eSubmissions can be found on the EMA website under eSubmission

The ICH M13B draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver reached Step 2b of the ICH Process on 13 March 2025 and entered the public consultation period.

The ICH M11 updated version of the Technical Specification document, which incorporates comments received during the first public consultation, reached Step 2b of the ICH process in March 2025 and now enters the second round of public consultation.

Act-HIB (Haemophilus type b conjugate vaccine (adsorbed))End of procedure: 21/10/2024Date of publication: 05/03/2025

Member: vacantAlternate: Elisa SulleiroAgencia Española del Medicamento y Productos SanitariosParque Empresarial Las MercedesEdificio 8C/Campezo 1ES-28022 MADRID

Member: Stavroula MamouchaAlternate: Eleni Katsomiti National Organization for MedicinesRegistration DivisionMesogion Avenue 284HolargosGR-15562 ATHENS

Report from the meeting held on 28-29 January 2025

Pamorelin LA 22.5 mg (triptorelin pamoate)End of procedure: 04/12/2024Date of publication: 06/02/2025