HavrixEnd of procedure:…
HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025
Pheniramine maleate, naphazoline…
Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date 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
ICH Q3E Draft Guideline is Available Now on the ICH Website
The ICH Q3E draft “Guideline for Extractables and Leachables” and supporting document has reached Step 2b of the ICH Process on 1 August 2025 and entered the Step 3 public consultation period.
LevosimendanDate of publication:…
LevosimendanDate of publication: 08/08/2025