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Introduction
This guidance applies to sponsors submitting applications to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). It:
- identifies the European Union guidelines for stability testing that have been adopted by the TGA for testing the active substance and the drug product
- explains additional information that may be required to include in Module 3 of the Common Technical Document (CTD) to demonstrate stability of the medicines under Australian conditions.
The information requested in this guidance is to be included in the relevant CTD modules.