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Stability testing for prescription medicines

6 March 2017

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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.


The guidance is divided into the following subsections:

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 1/07/2013

Shortened title and modified headings

Replacement of section 14.4: modification of specific requirements for biological medicines

Added hyperlinks to EU guidelines

Scientific Evaluation Branch; Laboratories Branch; Regulatory Guidance Team March 2017

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