This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information to be submitted for abbreviated or abridged applications, variations and clinical trial applications.

Keywords: Stability, stability testing, stability data, chemical active substance, finished product, specification, storage conditions

Current effective version

ICH: Q 1 A (R2): Stability testing of new drug substances and products - Step 5

AdoptedLegal effective date: Reference Number: CPMP/ICH/2736/99

English (EN) (248.29 KB - PDF)

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