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.
