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”.
The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period.
As ICH celebrates its 35th anniversary in 2025, DIA proudly honors its extraordinary impact on global health.
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.