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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]

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Pharma e AI, il punto con CPA Italy

L’Intelligenza Artificiale governa anche la ricerca e la produzione Pharma, attuale e del...

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New ICH Q1 guideline is ‘one-stop shop’ for stability testing

The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug...

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EU: dibattito sulle regole della sicurezza chimica

All’evento organizzato dal gruppo ECR al Parlamento europeo, l’Agenzia europea per le sostanze...

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