• Malaysia NPRA Updates Drug Registration Guidance Document (DRGD) with Revised Variation Timelines and Reliance Pathway

    Malaysia’s NPRA revises the DRGD, introducing updated processing timelines for pharmaceutical product variations and a reliance mechanism to enhance regulatory efficiency and international alignment.

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    NPRA | Pharmaceuticals | Regulatory Affairs

  • China: Adoption of ICH E6(R3) Good Clinical Practice

    Alignment with Global Clinical Trial Standards
    Regulatory Notice Date: January 7, 2026
    Compliance Effective Date: March 31, 2026

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    NMPA | Pharmaceuticals | Regulatory Affairs

  • China: Urgently Needed Overseas Drugs Policy Update

    Optimizing Review & Approval Pathways
    Effective from January 8, 2026

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    NMPA | Pharmaceuticals | Regulatory Affairs

  • 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