News dal mondo
07
Ago
UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline...[UK Parliament]
24
Ott
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...
le ultime news
08 Ago
European Commission: Lack of alternatives to TiO2 precludes ban in drugs
07 Ago
ICH Q3E draft “Guideline for Extractables and Leachables”
IPEC Risk Assessment Guide for Pharmaceutical Excipients
05 Ago
AIFA - Report sulla gestione della contaminazione da nitrosammine nei medicinali per uso umano da parte del network regolatorio europeo
01 Ago
Verso il Testo Unico della legislazione farmaceutica
30 Lug
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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