OUCRU and partners chart a “Roadmap to the Future of Clinical Trials in Vietnam”

OUCRU, in collaboration with Pharma Group and KPMG, launched the “Roadmap to the Future of Clinical Trials in Vietnam” report.

The report offers a comprehensive analysis of the country’s clinical research landscape, provides actionable strategies to position Vietnam among ASEAN’s top three clinical trial and R&D destinations by 2030, identifying key opportunities, barriers, and actions to unlock clinical research potential for economic and health impact.

Attending the launch ceremony were representatives from the Ho Chi Minh City Investment & Trade Promotion Centre, Ho Chi Minh City People’s Committee, as well as representatives from hospitals, universities, research institutes, and pharmaceutical and healthcare companies.

Representatives from OUCRU, Pharma Group, KPMG, and key stakeholders at the launch event of the “Roadmap to the Future of Clinical Trials in Vietnam” report

A vision for Healthcare Transformation Through Clinical Research

Over the past two decades, Vietnam has made sustained investments in expanding healthcare access and strengthening its public health system, achieving universal health insurance coverage for 95% of the population. As the country transitions to higher-quality care, innovation has emerged as a key priority—with clinical trials identified as a strategic pathway forward.

Vietnam has recently intensified efforts to enhance investment and implement policy reforms in this field. Notably, on December 22, 2024, the Politburo issued Resolution No. 57-NQ/TW, which outlines a commitment to developing domestic innovation capabilities and allocating 2% of GDP to R&D.

With a population exceeding 100 million, Vietnam offers vast potential for clinical research. Its diverse population structure is particularly well-suited for studying complex diseases, including cancer, cardiovascular disorders, infectious diseases, and metabolic conditions. These inherent advantages are further strengthened by government initiatives to improve the business environment, which are increasingly attracting global pharmaceutical companies and contract research organizations (CROs).

Clinical trials represent Vietnam’s next frontier for healthcare R&D advancement. From the innovative pharmaceutical industry’s perspective, Vietnam possesses strong potential to emerge as a competitive regional destination for clinical research. Realizing this ambition will require prioritized policies and initiatives that attract and facilitate clinical trial investments—particularly in early-stage trials. Such dedicated efforts and multi-stakeholder collaboration would unlock a multitude of economic, scientific, and health benefits, including: stimulating high-value research activity through infrastructure development and skilled job creation, strengthening Vietnam’s healthcare innovation ecosystem while creating cross-sector economic spillovers, and generating broader healthcare system benefits. This aligns perfectly with national strategies and Vietnam’s goal to become a top-three ASEAN destination for high-value investments. Pharma Group is committed to supporting the Government and healthcare stakeholders in charting the course forward—attracting clinical trials and advancing Vietnam’s R&D capabilities.

Dr Evelyne Keteslyn, Head of Clinical Trial Units at OUCRU, moderates the panel discussion on powering Vietnam’s healthcare innovation through clinical trials.

Unlocking Vietnam’s Clinical Trials Potential

In addition to opportunities, the report identifies five key challenges Vietnam must overcome: a lengthy and multi-step approval process that can take 6-12 months; limited research infrastructure with only 40 GCP-certified sites nationwide; a shortage of specialized human resources; a lack of structured funding mechanisms; and the absence of strong incentive policies to attract investment into this sector.

The report provides strategic recommendations to position Vietnam as a leading regional clinical trial destination, categorized into policy and non-policy measures with short-, medium-, and long-term implementation timeframes.

According to KPMG estimates, if these reforms are effectively implemented, Vietnam could reach 86 trials with a 24.3% compound annual growth rate (CAGR) and a market value of $749.5 million with an 88.6% CAGR by 2029. This would generate thousands of high-quality jobs, elevate Vietnam’s global standing in medical research and offer early access to cutting-edge treatments.

Policy recommendations focus on regulatory reforms, streamlined approval mechanisms, and investment incentives. Meanwhile, non-policy recommendations address infrastructure improvements, workforce and R&D capability development, dedicated clinical trial support, and public-private partnerships. Each recommendation identifies key stakeholders responsible for implementation and is supported by successful examples from other countries, providing a clear pathway to unlock the full potential of the country’s clinical trial sector.

Notably, to streamline review and clinical trial approval processes, Vietnam should: adopt bilingual documentation for both regulatory and reporting materials to enhance accessibility for international sponsors; implement a centralized online submission and electronic approval system to reduce timelines and eliminate redundancies; and introduce a fast-track pathway for trials already approved by regulatory authorities such as the US FDA, EU EMA, UK MHRA, or Japan PMDA.

To support advanced research, Vietnam also needs to expand its network of Good Clinical Practice (GCP)-certified facilities and establish standardized Clinical Trial Units (CTUs). Critically, the report recommends the establishment of a national Center of Excellence to serve as a platform connecting hospitals, research institutes, universities, and industry, a training hub for clinical researchers, an accelerator for trial approvals and global partnerships – ultimately positioning Vietnam as a competitive clinical research destination.

"The report ‘Roadmap to the Future of Clinical Trials in Vietnam’ represents the culmination of in-depth research, multi-stakeholder dialogue, and a shared vision for the sustainable development of Vietnam’s healthcare sector. We are proud to have partnered with the Oxford University Clinical Research Unit team in developing a comprehensive roadmap for the future of clinical trials in Vietnam. Our joint efforts underscore a shared vision to transform Vietnam’s clinical research landscape. We strongly believe that with the right policy framework and continued multi-stakeholder collaboration, Vietnam is poised to become a leading hub for clinical trials in Southeast Asia, driving sustainable growth and advancing healthcare innovation in the region.”

"We are confident that Vietnam can significantly enhance its clinical trial capabilities by embracing international best practices as demonstrated by key leading examples like Taiwan, Brazil, Poland, Malaysia, etc. By streamlining regulatory processes, investing in cutting-edge infrastructure, and fostering dynamic public-private partnerships, Vietnam can match global standards in trial efficiency and data integrity. This strategic alignment will not only drive innovation in therapeutic research but also position Vietnam as a regional hub for pioneering life-saving treatments."

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