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Testing of biological medicines

V1.0 December 2015

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This guidance applies to biological medicines, and outlines the current processes we use to test them during and after registration.

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Although these policies and processes have been in place since 2007, we are now publishing them as part of TGA's ongoing transparency initiatives.

Please note

Although included in the definition of biological medicines, this guidance does not apply to vaccines, anti-venoms and toxins.

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)). This will be described within guidance we are currently developing for post-registration testing of vaccines.

Version history
Version Description of change Author Effective date
V1.0 Original publication TGA 22/12/2015

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