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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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Massiccio reshoring farmaceutico negli Stati Uniti

Large pharmaceutical companies have promised to invest more than $370 billion over the next five years...

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EU health sector: New measures to make it more innovative, competitive and resilient

The European Commission has proposed an ambitious package of measures to improve the health of EU...

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EMA finalizes guideline on developing and manufacturing synthetic peptides

EMA has published a final guideline on synthetic peptide development and manufacture. The text will take...

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Riforma farmaceutica EU: Parlamento e Consiglio UE hanno trovato l'intesa

Parlamento e Consiglio UE hanno trovato l'intesa sulla riforma farmaceutica: un nuovo sistema di...

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