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EMA opens door to reliance on FDA GMP inspections conducted outside the US
The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration’s (FDA) findings from inspections of facilities outside the US. E EMA - Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 1st October 2025 [EMA/INS/GMP/369445/2024 – 1 ottobre 2025]
The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration’s (FDA) findings from inspections of facilities outside the US.
E EMA - Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 1st October 2025 [EMA/INS/GMP/369445/2024 – 1 ottobre 2025]
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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...
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