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REGULATORY UPDATE
Expansion of the Insulin Master File Procedure to Insulin Analogues
Published: 5/15/2026Detected: 3/25/2026

Summary preview

Expands WHO’s Human Insulin Master File (h-IMF) pilot procedure—originally for human insulin—to include insulin analogues, enabling protection of drug substance (DS) confidential know-how while ensuring finished product…

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infectious_disease
pediatrics
immunology
rare_diseases
manufacturing
quality
#WHO Prequalification
#insulin analogues
#insulin master file
#IMF
#h-IMF

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