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News from the world

18

Aug

US President signs executive order to fill the strategic stockpile of active pharmaceutical ingredients (APIs)

On 13 August, President Donald Trump issued an executive order directing the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) to identify 26 drugs that are essential for public health. The executive order also mandates that a six-month supply of active pharmaceutical ingredients (APIs) necessary for manufacturing these drugs be stockpiled. ASPR has 30 days to compile this list of essential drugs.

The executive order also directs ASPR to update the 2022 list of 86 essential medicines and to propose a plan for acquiring and storing a six-month supply of APIs for these medications...[RAPS]

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...

24

Oct

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...

24

Oct

US FDA Publishes Filing Checklists to Prevent Submission Delays

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...

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