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AI Safety 2026: The New Pharma Standard

AI Safety 2026: The New Pharma Standard - Regulated AI & Model Drift Monitoring AI Safety 2026: The New Pharma Standard - A comprehensive guide to regulated AI systems, model drift monitoring, and pharmaceutical compliance The pharmaceutical and medical device industries have officially moved past the "experimentation phase" of Artificial Intelligence. In boardrooms from Basel to Boston, the conversation has shifted from "Can AI help us?" to the more pressing question: "Is our AI safe, regulated, and ready for a clinical audit?" By end of 2025, the FDA had approved or cleared 1,016 medical devices using AI/ML technologies- nearly double the number from 2022. Yet regulatory scrutiny has intensified proportionally. The FDA and EMA jointly issued guiding principles in early 2026 establishing that AI governance in drug safety must be explainable, traceable, and inspection-ready -  no different from any other GxP-regulated system. This deep dive...
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Sandoz boosts Canadian production capacity

Sandoz boosts Canadian production capacity


Sandoz Canada, a unit of Novartis’ generics arm, has opened a second manufacturing plant at its site in Boucherville, Quebec, boosting local production capacity 66 per cent. The plant, which is due to be fully operational by mid September, comprises manufacturing, laboratory and warehousing space that the firm believes will give it the flexibility it needs to keep pace with increasing market demands. 


Richard Saynor, Head of Commercial Operations for Asia-Pacific, Latin America, Canada and Turkey says that: “The new plant in Boucherville is highly significant for our Canadian operations, and for Sandoz worldwide. It will enable us to triple our production capacity in both vials and ampoules. 


The new plant will manufacture a range of medicines, including opiate analgesics. We currently make 85 different molecules in Boucherville and the plant supplies products globally, although the bulk of sales are in Canada and the US.

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