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

We have adopted this International Scientific Guideline – ICH Q1A (R2); CPMP/ICH/2736/99

Last updated

18 December 2024

About this guideline

Overseas effective date: August 2003

Categories: ICH | Quality

Quality | Stability

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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