Australia's TGA opens consultation to revamp rules for digital mental health tools

The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to clarify requirements for safety, efficacy and data handling for these software‑based interventions.

The TGA is inviting input from developers, clinicians, patient groups and other stakeholders to shape the new guidelines. Feedback will help the agency balance innovation with patient protection as digital therapeutics become more common.

In a related regulatory update, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) highlighted in its 2025‑2026 annual report that it approved more new medicines than the previous year, removed a record number of illegal drugs from the market, and advanced its approach to artificial‑intelligence‑driven healthcare tools.

Both announcements reflect a broader trend of regulators adapting to rapid advances in digital health and AI, aiming to ensure that emerging therapies meet rigorous standards while supporting timely patient access.