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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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Version history

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

Book pagination