News from the world
12
Aug
FDA’s program to speed up US manufacturing buildouts
While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official...[PharmaManufacturing]
24
Oct
ECHA & REACh - SMEs to apply for company size validation before making REACH submissions
The European Commission has adopted the revised REACH Fee Regulation. Micro, small, and medium-sized...
Changes to e-submission requirements for CEP applications for 1 November 2025
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements...
US FDA Publishes Filing Checklists to Prevent Submission Delays
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...
22
Approvato dal Parlamento europeo il pacchetto “One substance, one assessment” - Regole UE più semplici e trasparenti per la chimica
Nell'ottica di semplificare l'assetto normativo e burocratico che impatta sulle imprese...
latest news
09 Sep
US internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify
08 Sep
Min. Salute UCS 29 agosto 2025 - Precursori di droghe - Regolamento UE 2025/1475 che estende il controllo a 2 nuove sostanze - In vigore dal 14 agosto 2025
18 Aug
US GDUFA IV: Industry wants more transparency
US President signs executive order to fill the strategic stockpile of active pharmaceutical ingredients (APIs)
12 Aug
AIFA - Novità rilascio, rinnovo e variazione AIC
11 Aug
FDA - Report on the State of Pharmaceutical Quality
WHO continues work on quality of medicines
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