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New ICH Q1 guideline is ‘one-stop shop’ for stability testing

The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, expand its scope, and incorporate more than three decades of related stability guidance documents under one umbrella....[RAPS]

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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...

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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...

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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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