News dal mondo
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US FDA Announces FY 2026 Animal Drug User Fee Rates for ADUFA and AGDUFA
The U.S. Food and Drug Administration has announced in the Federal Register the fiscal year (FY) 2026 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023...[FDA]
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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...
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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
30 Lug
EMA - Nitrosamine impurities
25 Lug
EU CRITICAL MEDICINE ACTS & Normative Ambientali
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