Tag: ICH Draft

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ICH Publishes a Draft M4Q(R2) guideline on common technical dossier (CTD)

ICH Publishes Draft M4Q(R2) Guideline to Transform CTD Quality Modules for Pharma Submissions

ICH releases draft M4Q(R2) to modernize CTD Quality Modules, aligning pharma submissions with QbD, lifecycle, and digital data expectations....
ich q1 stability testing draft released

ICH Q1 Draft Guideline Released for Comment: Consolidated Stability Framework Moves Forward

ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced...

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