News dal mondo
11
Mar
PFAS restriction proposal: ECHA’s Socio-Economic Analysis Committee agrees its draft opinion
The European Chemicals Agency’s Committee for Socio-Economic Analysis (SEAC) has agreed its draft opinion on the universal restriction proposal on all per- and polyfluoroalkyl substances (PFAS). The draft opinion will be published soon for a 60-day consultation...[ECHA]
13
Dal China all’India-shoring, il rischio di una nuova dipendenza
Una ricerca universitaria, promossa da CPA Italy, sulla supply chain di principi attivi e intermedi mostra...
EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection
A final version of the draft pharma reform package has been published, clarifying changes that the...
Farmaci - Gemmato: In cantiere anche un ritorno nazionale alla chimica farmaceutica di base
Il sottosegretario alla Salute Marcello Gemmato è intervenuto durante la presentazione del Rapporto...
EMA outlines methods for evaluating supply chain vulnerabilities
The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring...
le ultime news
11 Feb
AIFA - Aggiornamento della Nota esplicativa relativa alla procedura del “silenzio/assenso” in accordo con la nuova EC Classification Guideline sulle variazioni
AIFA - Nuova modalità Multi-Beneficiario per i pagamenti online delle tariffe previste dal D.M. 6 dicembre 2016
09 Feb
Pharma expert discusses effort to standardize CMC quality information
06 Feb
US FDA proposes waiving GDUFA facility fees for domestic manufacturers
Computer Software Assurance for Production and Quality Management System Software
04 Feb
FDA, EMA officials encourage companies to pilot eCTD 4.0
03 Feb
China revises drug administration regulations to spur innovation, tighten oversight
02 Feb
USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.
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