• EMA Pharmacovigilance Update – New GVP Module Revisions & Signal Management Enhancements

    December 2025, the EMA issued updates to its Good Pharmacovigilance Practices (GVP) framework, including revisions to GVP Module IX (Signal Management) and updated guidance for Periodic Safety Update Reports (PSURs). Enhancements focus on risk signal detection methods, data analytics integration, and improved transparency in safety communication processes.

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    EMA | Pharmaceuticals | Pharmacovigilance

  • FDA Electronic Submissions Gateway Next Generation (ESG NextGen) Notice

    FDA announced that the legacy ESG certificate expiring Dec 26, 2025 does not require renewal for ESG NextGen use. Users on Chrome 142+ or Edge 143+ may see a temporary “open in new tab/window” prompt when uploading via FileCatalyst. Submission teams should verify browser workflows.

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    FDA | Pharmaceuticals | Publishing & Submissions

  • Regulatory Guidelines for Adding/Transferring Human & Veterinary Pharmaceutical Manufacturing Sites

    Explore the regulatory process for adding or transferring human & veterinary pharmaceutical manufacturing sites, outlining key requirements, classification criteria, and submission expectations.

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    Egyptian Drug Authority (EDA) | Pharmaceuticals | Regulatory Affairs

  • China: Revised Drug Approval Access & Publication of Latest Approved Drug List

    Enhancing Regulatory Transparency, Digital Certificate Access & Industry Compliance
    Effective from December 9, 2025

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    NMPA | Pharmaceuticals | Regulatory Affairs

  • Vietnam: Issuance & Renewal of Nearly 600 Drug Registrations

    Strengthening Market Access, Compliance & Bioequivalence Standards
    Effective from December 6, 2025

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    MOH | Pharmaceuticals | Regulatory Affairs