ICH Q3E Step 2 Presentation Now Available on the ICH Website
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.
Pheniramine maleate, naphazoline…
Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date of publication: 25/09/2025
2025, Q1-Q2 – Statistics for New…
2025, Q1-Q2 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
HavrixEnd of procedure:…
HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025
The ICH M14 Guideline reaches Step 4 of the ICH Process
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:…
Member: Helen VellaAlternate: Paula Cardona Xuereb Awtorità dwar il-MediċiniSir Temi Zammit BuildingsMalta Life Sciences ParkMT-SGN 3000 San Gwann
Member: Andrzej…
Member: Andrzej CzeslawskiAlternate: Pawel Pawlowski Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAl. Jerozolimskie 181CPL-02-222 Warszawa
Member: Marta…
Member: Marta Marcelino Alternate: Rui Pedro da Costa Vilar INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA
Member: Christin…
Member: Christin OlofssonAlternate: Adam Andersson Medical Products AgencyDag Hammarskjölds väg 42SE-751237 UPPSALA
Member: Vlasta Zavadova Office of…
Member: Vlasta Zavadova Office of HealthÄulestrasse 51LI-9490 Vaduz