Radiopharmaceutical regulation in Australia - Open public consultation

Overview

The Therapeutic Goods Administration (TGA) is seeking high‑level stakeholder feedback on how current regulatory settings for radiopharmaceuticals operate in practice. This consultation is intended to support informed consideration of stakeholder experiences with existing regulatory pathways, exemptions and access mechanisms. Feedback received will be used to inform future targeted consultation and engagement activities.

To support stakeholder feedback, the TGA has provided an information paper (related document below) outlining, at a high level, how current regulatory pathways operate in practice. The paper is intended to assist stakeholders and should be considered alongside relevant legislation and guidance.