News dal mondo
09
Feb
Pharma expert discusses effort to standardize CMC quality information
The pharmaceutical industry and the US Food and Drug Administration (FDA) are collaborating on a structured...
06
US FDA proposes waiving GDUFA facility fees for domestic manufacturers
The US Food and Drug Administration (FDA) has proposed waiving annual facility fees for the first three...
Computer Software Assurance for Production and Quality Management System Software
FDA is issuing this guidance to provide recommendations on computer software assurance for computers...
04
FDA, EMA officials encourage companies to pilot eCTD 4.0
Companies should increase their efforts to address issues and test their electronic Common Technical...
le ultime news
12 Dic
Legislazione farmaceutica EU: Accordo sulla riforma
Riforma farmaceutica, accordo trovato in UE
Revisione normativa UE sul Pharma: raggiunto l’accordo tra Consiglio e Parlamento
10 Dic
Promozione della ricerca pubblica: AIFA invita gli stakeholder a proporre aree di ricerca sui medicinali
Il Consiglio dell'UE porta avanti il Critical Medicines Act con nuovi emendamenti
AIFA a Milano: nasce una nuova era di collaborazione tra l’Agenzia e le Regioni
EDQM releasesEDQM - draft revised “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”
05 Dic
Farmaci essenziali sempre più scarsi: la Corte UE avverte sulle falle del sistema
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