A Strategic Advantage In April 2026, the Therapeutic Goods Administration (TGA) updated its guidance on pre-submission meetings for medicines and biologicals. This signals emphasis on early, structured engagement between sponsors and regulators. For regulatory teams, this is not a procedural update; it is a strategic opportunity to reduce submission risk, enhance clarity, and avoid costly…
Lessons from the March 2026 TRUE METRIX device correction In March 2026, the Therapeutic Goods Administration (TGA) published a market action for the TRUE METRIX® Blood Glucose Monitoring Systems, describing a product correction prompted by gaps in the clarity of the Instructions for Use (IFU). On the surface, the issue related to a single device…
What the TGA’s New Market Action Framework Means in Practice The Australian Therapeutic Goods Administration (TGA) fundamentally reshaped how sponsors manage recalls and other market actions when the Procedure for Recalls, Product Alerts and Product Corrections (PRAC) came into effect on 5 March 2025, and published a revision on 24 February 2026 . This change…
Using regulatory transparency as a proactive planning tool for sponsors and manufacturers The Therapeutic Goods Administration (TGA) updated its GMP Clearance Sponsor Information Dashboard (SID) on 10 March 2026 as the regulator continues its efforts to reduce the GMP Clearance backlog. The SID now provides rolling views of processing timeframes, workload volumes and application quality…
MHRA Updates and Global Alignment for Product Recalls Defective medicinal products are under sharper regulatory scrutiny than ever. In early 2026, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated Guide to Defective Medicinal Products, signalling a refreshed emphasis on rapid defect detection, structured investigations, and decisive recall process. In Australia,…
Budget Planning for Manufacturers Manufacturers operating in Australia face a continually evolving fee environment, with the Therapeutic Goods Administration (TGA) updating its fees and charges annually through cost‑recovery frameworks. For FY2026, the primary indicators came from the TGA’s 2025–26 proposals and the fee schedules published in mid‑2025. These determine the cost structures applicable from 1…
Regulatory Oversight, SPF Compliance and Lessons for Industry Australia relies on sunscreen more than most countries. Yet in 2025, a wave of reporting and consumer testing challenged a core assumption that the SPF printed on the label consistently reflects the protection delivered in real-world products. CHOICE testing reported that 16 of 20 sunscreens did not…
For therapeutic goods manufacturers, regulatory change is constant. An effective regulatory intelligence capability ensures you detect, analyse, and operationalise updates across jurisdictions (FDA, EMA/EU GMP, PIC/S, TGA, WHO) before inspections or market events force reactive action. Regulatory intelligence connects horizon scanning with change control, training, supplier oversight and validation so your Pharmaceutical Quality System (PQS)…
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