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.

What happens next

Feedback received through this consultation will be analysed at a high level and considered alongside existing operational experience and policy work within the department, as well as with relevant input from previous engagement and consultation activities, including the targeted consultation undertaken in 2025.

The feedback will help to:

• identify common themes regarding the clarity, consistency and usability of current regulatory pathways
• highlight areas where additional guidance, education material or engagement may assist stakeholders
• inform future planning, including whether more targeted stakeholder discussions or workshops would be beneficial.

Feedback from this consultation will not, of itself, result in immediate regulatory changes. A summary of responses may be published in aggregate form, subject to confidentiality requests.