South Korea has transformed into a leading destination for global clinical trials, leveraging its advanced healthcare infrastructure and strategic government support to attract international pharmaceutical research. With a pharmaceutical market projected to reach $20 billion by 2015, the country has positioned itself as a premium location for clinical research in Northeast Asia.
Regulatory Excellence and Government Support
The Korean Ministry of Food and Drug Safety (MFDS) has implemented one of Asia's most efficient regulatory frameworks for clinical trials. The process, aligned with International Conference on Harmonisation (ICH) guidelines, features expedited study start-up times and well-defined review procedures. Institutional Review Board (IRB) approvals typically complete within one to two months, significantly accelerating research timelines.
The government's commitment to biotechnology advancement dates back to the 1980s, culminating in several strategic initiatives. In 2007, the Korea National Enterprise for Clinical Trials was established to enhance research standards and foster industry partnerships. This was followed by the 2011 launch of the Korea Drug Development Fund, backed by a substantial $1 billion budget to catalyze new drug development.
Advanced Infrastructure and Research Capabilities
Korea's clinical trial infrastructure rivals Western standards, featuring 15 major regional medical centers and over 164 investigational trial sites nationwide. The country's research facilities particularly excel in oncology trials, which represent approximately one-third of all global trials conducted locally. Additionally, Korea ranks among the top five globally for stem cell research clinics.
Strategic Advantages for International Research
Several factors make Korea particularly attractive for clinical research:
- Western-style medical infrastructure with state-of-the-art facilities
- High English proficiency among medical professionals
- Nearly 100% literacy rate, simplifying informed consent processes
- Strong doctor-patient relationships supporting high trial retention rates
- Growing prevalence of Western diseases, providing relevant patient populations
International Industry Presence
Major global Contract Research Organizations (CROs) have established significant operations in Korea. Quintiles, operating since 2000, maintains one of its largest East Asian offices in the country. ICON, active since 2005, manages nearly 100 protocols locally. Recent partnerships between the Korea Drug Development Fund and international CROs like WCCT Global, PAREXEL, and Novotech further strengthen the country's position in global clinical research.
Future Growth Trajectory
The Korean government continues to demonstrate its commitment to biotechnology advancement through new initiatives. Recent announcements by President Park Geun-Hye outline plans to expand stem cell research facilities, increase researcher training, and broaden the scope of disease research. These ongoing investments and improvements in research infrastructure position Korea to achieve its goal of becoming a world leader in biomedical research and development by 2020.