In follow up to the publication of the ICH M4Q(R2) draft revised Guideline in May 2025, the EWG has also prepared a Step 2 informational presentation.

The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period.

The ICH E21 draft Guideline on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” reached Step 2b of the ICH Process in May 2025 and has entered the consultation period.

IMPLEMENTATION OF THE VARIATIONS FRAMEWORK Marketing authorisation holders (MAHs) and national competent authorities should follow certain principles to facilitate a smooth transition to the new variations framework. Type-IB and II variations (including grouped Type-IA variations) For Type-IB and / or Type-II variations submitted before 15 January 2026:  These types of variations will follow the current [...]

VARIATIONS FRAMEWORK Variations Regulation The revised Variations Regulation applies since 1 January 2025 for variation applications implemented and submitted from 1 January 2025. Variations Guidelines A single cut-off date for the entry into application (i.e., 15 January 2026) is set out in the final version of the Variations Guidelines. Until 15 January 2026, marketing authorisation [...]

Bilaxten and associated names (bilastine)End of procedure: 03/02/2025Date of publication: 28/05/2025

The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May, in Madrid, Spain in parallel of meetings of 11 Working Groups preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.

The ICH Secretariat is pleased to announce the publication of the ICH Q5A(R2) “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” Guideline training materials.

Member: Daniela Elena Popa National Medicines Agency and Medicinal Devices of Romania48, Aviator Sanatescu Street, Sector 1011478 BucharestRomania

The version allows the selection of Reference Member State and Concerned Member State(s) when the type of authorisation is “National Authorisation” and the type of application is “Super-grouping”.