Australia’s TGA Updates Testing Guidance for Biologicals
The Australian Therapeutic Goods Administration (TGA) has released updated guidance on the testing of biological drugs to reflect its most current practices.
The guidance document — which doesn’t apply to vaccines, anti-venoms or toxins — provides drugmakers with information on the agency’s testing requirements and processes for biologicals, both during and after registration.
Updates include new formatting, which gives clearer guidance on the agency’s risk assessment process and initial risk groups for new biologicals. In addition, the latest guidance provides more detail on the TGA’s current testing methods.