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    Day: February 12, 2026

    Periodic Safety Update Reports (PSUR) in Pharmacovigilance: Regulatory Expectations and Inspection Impact in 2026

    Digital safety data analysis interface used for signal detection, post-marketing surveillance, and regulatory inspections in pharmacovigilance and drug safety reporting.

    Periodic Safety Update Reports now function as inspection evidence, enabling regulators to evaluate ongoing safety surveillance, benefit–risk assessment, and pharmacovigilance system control across the product lifecycle, rather than treating PSURs as regulatory submissions.

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