Clinical Trials in Vietnam: A Decade of Progress and the Next Policy Steps
April 10, 2026
On June 27, 2025, the Department of Science, Technology and Training (Ministry of Health) organized a workshop titled “Review of New Product Research and Development Activities (2015–2025) and Consultation on the Draft Circular Replacing Circular No. 29/2018/TT-BYT on Clinical Drug Trials.” The workshop was attended by leaders of the National Ethics Committee in Biomedical Research, along with experts, policymakers, representatives from hospitals, research institutes, universities, enterprises, and international organizations conducting clinical trials in Vietnam.
Over the past decade, Vietnam has made significant progress in the research and development of pharmaceuticals, vaccines, and other medical products. Many innovations developed by domestic scientists and enterprises have approached international standards, contributing to elevating Vietnam’s position on the regional biomedical research map. In parallel, the clinical trial governance system has been gradually strengthened, with an increasingly harmonized legal framework aligned with international standards – ensuring scientific rigor, transparency, and a participant-centered approach to safety and rights.
Despite these achievements, the workshop also highlighted key challenges. Institutional frameworks and policies require further updates to meet the demands of innovation, digital transformation, and global integration, in line with Resolution No. 57-NQ/TW of the Politburo. The development of a new Circular to replace Circular 29/2018/TT-BYT has therefore become an urgent priority – both to ensure robust oversight of clinical trials and to create an enabling environment for the development of high-quality medical products for patients.
The workshop served as an important forum for organizations directly involved in clinical trial implementation to share practical experiences, challenges, and recommendations. These contributions will support the Department of Science, Technology and Training in refining the draft Circular to ensure feasibility, consistency, and alignment with international integration requirements.
In this context, Vinmec – VinUni recognizes its responsibility to collaborate with national regulatory systems in driving innovation. Leveraging the integration of a high-quality, multidisciplinary hospital system and a research-oriented university, Vinmec – VinUni is developing a clinical trial model aligned with ICH-GCP standards, with strong emphasis on quality management, data governance, and participant protection through the following initiatives:
- Proactively updating, adopting, and rigorously implementing new clinical trial regulations once the replacement Circular is issued.
- Sharing practical experience from conducting multicenter, multidisciplinary studies to support the development of a regulatory framework that is both robust and innovation-friendly.
- Investing in research infrastructure and training physicians, nurses, and study coordinators to meet GCP standards in quality management and research ethics—thereby strengthening Vietnam’s overall clinical trial capacity.
- Promoting the adoption of digital technologies in research management (e.g., eISF, e-CTMS, electronic signatures, electronic document archiving), in line with the healthcare sector’s digital transformation agenda.
Through professional excellence and collaboration with regulatory authorities and both domestic and international partners, Vinmec – VinUni aims to become a trusted destination for high-quality clinical trials – contributing meaningfully to Vietnam’s healthcare innovation ecosystem and bringing advanced therapies closer to patients.
REFERENCES
- (2025) Hội thảo đánh giá 10 năm hoạt động nghiên cứu phát triển sản phẩm mới và góp ý dự thảo Thông tư thay thế Thông tư 29/2018/TT-BYT quy định về thử thuốc trên lâm sàng. Cục Khoa học công nghệ và Đào tạo – Bộ Y tế. Cục Khoa học công nghệ và Đào tạo – Bộ Y tếhttps://asttmoh.vn/hoi-thao-danh-gia-10-nam-hoat-dong-nghien-cuu-phat-trien-san-pham-moi-va-gop-y-du-thao-thong-tu-thay-the-thong-tu-29-2018-tt-byt-quy-dinh-ve-thu-thuoc-tren-lam-sang/.
- Thành tựu vaccine Việt Nam: Biến khát vọng thành hiện thực (2025). Báo Nhân dân – Số đặc biệt kỷ niệm 80 năm Cách mạng Tháng Tám và Quốc khánh 2/9. https://nhandan.vn/thanh-tuu-vaccine-viet-nam-bien-khat-vong-thanh-hien-thuc-post902619.html
