News from the world
24
Oct
ECHA & REACh - SMEs to apply for company size validation before making REACH submissions
The European Commission has adopted the revised REACH Fee Regulation. Micro, small, and medium-sized...
Changes to e-submission requirements for CEP applications for 1 November 2025
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements...
US FDA Publishes Filing Checklists to Prevent Submission Delays
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...
22
Approvato dal Parlamento europeo il pacchetto “One substance, one assessment” - Regole UE più semplici e trasparenti per la chimica
Nell'ottica di semplificare l'assetto normativo e burocratico che impatta sulle imprese...
latest news
08 Aug
European Commission: Lack of alternatives to TiO2 precludes ban in drugs
07 Aug
ICH Q3E draft “Guideline for Extractables and Leachables”
IPEC Risk Assessment Guide for Pharmaceutical Excipients
UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing
05 Aug
AIFA - Report sulla gestione della contaminazione da nitrosammine nei medicinali per uso umano da parte del network regolatorio europeo
01 Aug
Verso il Testo Unico della legislazione farmaceutica
30 Jul
FDA’s Office of Pharmaceutical Quality Releases a White Paper on the Economics of Quality Management Incentives
US FDA Announces FY 2026 Animal Drug User Fee Rates for ADUFA and AGDUFA
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