Q1A(R2)-ICH STABILITY GUIDELIENS
The following guideline is a revised version of the ICH Q1A guideline and defines the
stability data package for a new drug substance or drug product that is sufficient for
a registration application within the three regions of the EC, Japan, and the United
States. It does not seek necessarily to cover the testing for registration in or export to
other areas of the world.
The guideline seeks to exemplify the core stability data package for new drug
substances and products, but leaves sufficient flexibility to encompass the variety of
different practical situations that may be encountered due to specific scientific
considerations and characteristics of the materials being evaluated. Alternative
approaches can be used when there are scientifically justifiable reasons.
The guideline addresses the information to be submitted in registration applications
for new molecular entities and associated drug products. This guideline does not
currently seek to cover the information to be submitted for abbreviated or abridged
applications, variations, clinical trial applications, etc.
Specific details of the sampling and testing for particular dosage forms in their
proposed container closures are not covered in this guideline.
Further guidance on new dosage forms and on biotechnological/biological products
can be found in ICH guidelines Q1C and Q5C, respectively.
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