TGA Posts Guide for Submitting Drug Designation Extensions

Australia’s Therapeutic Goods Administration released a step-by-step guide for agents and sponsors wishing to apply for an extension of a previously approved prescription medicine, orphan drug or provisional determination.

The applications submitted through TGA’s online business services portal require a TGA client ID number and access to the online portal.

To receive a client ID an agent or sponsor must first submit an online organization detail form to the agency before filling out an extension application.