Australia – TGA Updates Guidance on the Testing of Biological Medicines

Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.

TGA published the first, and until this week only, version of the guidance in 2015. In revising the guide, TGA has reformatted and updated the text to bring it in line with its current practices, while also adding a new section on the use of the in-house orthogonal testing methods that the agency is increasingly using.

When TGA tests biologicals, it uses its validated in-house methods and internal acceptance criteria based on either the most stringent specifications or an average from approved specifications of the medicines being assessed.