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Testing of biological medicines

Applicable to biological medicines, excluding vaccines, anti-venoms and toxins

19 July 2019

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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:

  • vaccines
  • anti-venoms
  • toxins

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

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