• Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products

    FDA Issues Final Guidance on Promotional Labeling and Advertising Considerations for Reference, Biosimilar, and Interchangeable Biosimilar Products

  • China: Draft Guidelines on Export Drug Inspections & Certificates

    Ensuring Compliance and Quality Management for Drug Exports

    Published: 21-Nov-2025

  • China: Technical Guidelines for Common Problems in Drug Development and Clinical Trial Application (Draft for Comments)

    Enhancing Regulatory Communication and Drug Development Quality

    Published: 18-Nov-2025

  • China: Draft Guidelines for Electronic Data in Clinical Trials (For Comments)

    Strengthening data integrity and system validation.

    Published: 24-Nov-2025

  • Saudi Arabia: SFDA Links National Pharmacovigilance Database with WHO Global Platform

    Enhancing Drug Safety Through Global Data Integration

    Published: 24-Nov-2025