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...
Alembic seeks to mix it with US and European players Indian pharmaceutical firm Alembic is seeking to expand its presence in the lucrative US and European drug markets through an expanded partnering programme. The Gujarat-headquartered group, which is involved in both the active pharmaceutical ingredient (API) and pharmaceutical formulation markets, aims to grow internationally and double its annual turnover over the next two to three years, according to a report in India’s Business Standard. Company director Pranav Amin explained that the firm intends to file about 10-12 ANDAs every year and to tap potential in the generic markets of the US and Europe. The company has also submitted around 22 drug master file (DMF) requests to regulatory agencies in Europe and the US in recent years in a bid to boost its roster of API clients.