• China: Special Drug Approval Certificate – Electronic License Access Update

    Streamlined Access to NMPA Electronic Drug Approval Certificates

    Effective from 17-Nov-2025

    Electronic license access available since 26-Mar-2024

  • JFDA Issues Circular on Analysis Requirements for Post-Marketing Products

    Post-marketing surveillance analysis requirements for controlled products and compliance with laboratory testing before distribution.

  • China: Draft Guidelines for Manufacturing & Testing of Recombinant Monoclonal Antibody Biopharmaceuticals Open for Public Comment

    Strengthening standardization in biologics manufacturing & QC

    Released on November 10, 2025 Open until 09-Jan-2026

  • Saudi Arabia: SFDA Enhances Collaboration with Health Authorities to Advance Medicine Safety

    Advancing national drug quality & adverse event reporting

    Released on November 11, 2025

  • Saudi Arabia: Guideline on Requirements for Biosimilar Development & Approval

    Stay Compliant with SFDA’s Latest Biosimilar Requirements

    Effective from 10-Nov-2025 Open for public comment until 09-Jan-2026