Analysing the implications of the draft Annex 22 for AI integration and digital transformation The pharmaceutical industry is on the brink of a digital revolution, and the draft GMP Annex 22 Artificial Intelligence signals a major shift in regulatory expectations for AI and digitalisation in GMP environments. We have previously reviewed the content of the…
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…
How external safety bulletins can strengthen your internal quality system Regulators routinely publish a wide range of external safety communications including alerts, advisories, recall notices, and safety roundups. Many organisations treat these communications as background noise but, in reality, these publications are a powerful and underused resource. They contain a wealth of regulatory signals about…
Navigating Medical Device Regulation Revisions and New Harmonised Standards The global medical device and in vitro diagnostics (IVD) sector is entering 2026 amid one of the most significant regulatory transformations since the introduction of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation (MDR/IVDR). The European Commission and expert bodies have recently released…
A Game-Changer for Facility Design and Construction The announcement of the United States Food and Drug Administration (FDA) PreCheck Initiative in August 2025 marked a meaningful shift in how pharmaceutical manufacturing facilities can be planned, designed, and brought into operation in the US. Rather than waiting until construction is complete with a product application then…
Supporting resilience, performance, and wellbeing across therapeutic goods manufacturing Working in Good Manufacturing Practice (GMP) regulated environments has never been a low‑pressure endeavour. The responsibility to ensure patient safety, product quality, and regulatory compliance carries inherent stress, and this pressure has only intensified in recent years. As regulatory scrutiny increases, global supply chains remain fragile,…
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