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News dal mondo

01

Feb

EMA update on shortages of antibiotics in the EU

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU. The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA).

A recent surge in respiratory infections has driven an increase in demand for amoxicillin which combined with other issues including manufacturing delays and production capacity challenges led to shortages affecting the majority of Member States...[EMA]

24

Mar

AIFA - Criteri per l’attribuzione di distinti numeri di AIC in fase di domanda di nuova AIC/estensione o a seguito di variazione

Si informano i Titolari AIC che, al fine di rendere trasparenti i criteri adottati dall’Agenzia...

23

Mar

IMS Micronizzazioni: “Making Pharmaceuticals per parlare delle ultime novità in campo di micronizzazione”

Il settore farmaceutico si riunisce a Milano per fare il punto sulle ultime novità e sulle prospettive...

23

Mar

EDQM - What is the CEP 2.0 and what will change?

The CEP 2.0 (new name of the CEP of the future) is a “new-look” CEP that will better meet...

17

Mar

EMA - EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME

Audit Checklist (Revision 3 including API and common with Canada and PIC/S).. [EMA]

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