Australian regulator TGA opens consultation on automated decision making for listed medicine variations
The Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicines.
The aim is to streamline the review process, allowing routine changes to be assessed by software rather than manual evaluation, while maintaining safety standards.
Stakeholders are invited to comment on the draft approach, including how data quality, transparency and oversight will be ensured.
The consultation period runs for several weeks, after which the TGA will consider the feedback before finalising the regulatory framework.
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “Asia-Pacific Roundup: TGA seeks feedback on automated decision making for changes to listed medicines”
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