News dal mondo
24
Set
FDA finalizes production and quality system software guidance
US FDA Guidance for Industry - Computer Software Assurance for Production and Quality System Software
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
14 Ott
Critical Medicines Act europeo, nuova proposta di legge per garantire fornitura farmaci e principi attivi
10 Ott
EMA opens door to reliance on FDA GMP inspections conducted outside the US
EDQM seeks feedback on plans to add glycol adulteration section to monographs
02 Ott
Testo unico della legislazione farmaceutica in itinere: strategia per riportare produzione in Europa
AIFA Nuovo sistema informatico Workflow Officine Materie Prime
26 Set
Medicines for Europe voices shock at ‘concerted efforts’ to water down CMA
Ministero Salute - Riportare in Italia la grande produzione farmaceutica di base
24 Set
FIS investe 20 milioni per rafforzare la capacità produttiva
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