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:
|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|