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Testing of biological medicines
Applicable to biological medicines, excluding vaccines, anti-venoms and toxins
This guidance applies to sponsors of biological medicines, and outlines:
- requirements of our testing program during and after registration
- how we apply a risk-based approach to prioritising our testing program
These policies and processes have been in place since 2007 and are published as part of TGA's ongoing transparency initiatives.
While the following products are included in the definition of biological medicines, this guidance does not apply to:
Requirements for vaccine testing
Post-registration testing of vaccines complies with internationally accepted guidelines (most recently published in Annex 2 of the WHO Technical Report Series (TRS 978) (pdf,439kb)).
|Version||Description of change||Author||Effective date|
|V2.0||Original document re-formatted and updated to reflect the latest practices, introducing information on use of TGA in-house orthogonal testing methods.||Biochemistry Section Regulatory Guidance Team||July 2019|