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
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Member: Andrzej CzeslawskiAlternate: Pawel Pawlowski Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAl. Jerozolimskie 181CPL-02-222 Warszawa
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Member: Christin OlofssonAlternate: Adam Andersson Medical Products AgencyDag Hammarskjölds väg 42SE-751237 UPPSALA
Member: Vlasta Zavadova Office of HealthÄulestrasse 51LI-9490 Vaduz