Stability testing for prescription medicines

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.