News dal mondo
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GMP UPDATING - EU Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1 Pharmaceutical Quality System
Eu European Commission Consultation - Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1 Re Revision of Good Manufacturing Practice (GMP) Guidelines: Chapter 1 Pharmaceutical Quality System Ä3 3 settembre – 3 dicembre 2025: Invio commenti
Eu European Commission Consultation - Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1
Re Revision of Good Manufacturing Practice (GMP) Guidelines:
Ä3 3 settembre – 3 dicembre 2025: Invio commenti
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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...
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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...
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AIFA - Report sulla gestione della contaminazione da nitrosammine nei medicinali per uso umano da parte del network regolatorio europeo
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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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