On December 31, 2025, the Ministry of Health of Vietnam issued Circular 50/2025/TT-BYT, providing updated regulations on clinical trials. The Circular takes effect from February 27, 2026, replacing previous regulations and creating a more comprehensive legal framework for clinical research in Vietnam .
The Circular clearly defines the scope of clinical trials, including requirements for Good Clinical Practice (GCP), clinical trial documentation, and study procedures. It reinforces that clinical trials must ensure data reliability, subject safety, and protection of participant confidentiality throughout the research process .
A key update is the structured system for GCP compliance assessment, including:
- Initial evaluation for new clinical trial sites
- Periodic re-assessment every 3 years
- Risk-based and ad-hoc inspections when needed
These measures strengthen quality control and ensure continuous compliance of trial sites .
The Circular also provides detailed guidance on:
- Clinical trial application dossiers and approval process
- Requirements for Investigator’s Brochure (IB), Case Report Forms (CRF), and informed consent
- Clear timelines for regulatory review and approval
- Responsibilities of sponsors, investigators, and trial sites
In addition, the regulation ensures alignment with updated ICH-GCP and WHO standards, with mechanisms to quickly adopt international updates into Vietnam’s regulatory system .
Overall, Circular 50 represents a significant step forward in improving regulatory clarity, transparency, and quality standards for clinical trials in Vietnam. It creates a more favorable environment for both local and international sponsors to conduct clinical research efficiently and in compliance with global standards. Please refer to the English translation of the Circular below.
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