In follow up to the publication of the ICH Q3E draft “Guideline for Extractables and Leachables” in August 2025, the Q3E EWG has also prepared a Step 2 informational presentation.

The ICH Secretariat is pleased to announce the release of E11A Pediatric Extrapolation Training Module 1 - Case Example: Development of a hypothetical TNF-alpha inhibitor "Drug X" for the treatment of polyarticular juvenile idiopathic arthritis (pJIA).

HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025

Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date of publication: 25/09/2025

2025, Q1-Q2 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

The ICH M14 Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines” has reached Step 4 of the ICH Process on 04 September 2025 and has now entered the implementation phase at Step 5 of the ICH Process

Member: Helen VellaAlternate: Paula Cardona Xuereb Awtorità  dwar il-MediċiniSir Temi Zammit BuildingsMalta Life Sciences ParkMT-SGN 3000 San Gwann

Member: Andrzej CzeslawskiAlternate: Pawel Pawlowski Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAl. Jerozolimskie 181CPL-02-222 Warszawa

Member: Marta Marcelino Alternate: Rui Pedro da Costa Vilar INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA

Member: Christin OlofssonAlternate: Adam Andersson Medical Products AgencyDag Hammarskjölds väg 42SE-751237 UPPSALA