Global Health Authority Mandates

EU Regulation: Sponsor Handbook: Clinical Trial Information System (CTIS) User Guidance

This guidance was published by the European Medicines Agency (EMA), and it serves as a comprehensive guide for sponsors on how to use the CTIS, which is a system designed to streamline the submission and management of clinical trials in accordance with the EU Clinical Trials Regulation (EU CTR).

Consult our EU CTR experts to know more

China: NMPA Updates Drug Approval Document Delivery & Publishes Latest Approvals

Latest updates on electronic certificate access & newly approved medicinal products

Released on November 11, 2025

FDA Accelerates E2B(R3) Transition to Modernize Electronic Safety Reporting by 2026

The FDA advances its transition to E2B(R3) standards for electronic safety report submissions, releasing updated guidance, validation tools, and timelines to support FAERS testing and 2026 compliance.

Vietnam: Decision No. 629/QD-QLD – Extension of Registration Certificates for 05 Vaccines and Biological Products (Batch 57)

Supporting Continuous Access to Authorized Vaccines in Vietnam

Released on October 31, 2025

Vietnam: Official Dispatch No. 1841/YDCT-QLD – List of Minor Changes Requiring Only Notification (Batch 2)

Streamlining Post-Approval Change Notifications for Traditional Medicines

Released on November 5, 2025