• 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.

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

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

  • Vietnam: Issuance & Renewal of Nearly 600 Drug Registrations

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

  • Labeling compliance deadline for medicines under simplified notification

    ANVISA Reinforces Deadline for Labeling Compliance for Simplified Notification Medicines

  • Malaysia NPRA Updates Compliance Requirements for Serious Breach Reporting

    Reporting and managing serious breaches in clinical trials as per NPRA requirements