An international pilot that allowed companies to have their applications for increasing drug manufacturing capacity to be simultaneously evaluated by multiple regulatory authorities has yielded positive results for industry and is to be continued throughout 2025.
Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.