Emerging markets play an increasingly important role in clinical research. Amongst these, South Korea has distinguished itself as a prominent destination for clinical trials.
Historically, clinical trials were predominantly conducted in North America and Western Europe. However, by 2021 approximately half of all the clinical trial starting in that year included a trial site in APAC.1 This shift has been driven by factors such as the need for larger and more diverse patient populations, cost considerations, and the globalisation of the pharmaceutical industry.
South Korea's emergence can be traced back to the early 2000s when the country's government recognised the potential of clinical research to be a significant contributor to economic growth. What followed was a series of strategic initiatives aimed at developing South Korea's capacity for conducting high-quality clinical research.
According to data from Citeline’s Trialtrove®, the number of clinical trials conducted in South Korea increased from just 48 in 2000 to over 1,000 annually by 2021.2 This represents a growth rate far exceeding the global average.
The significance of South Korea's emergence represents a shift in the global distribution of clinical research capabilities, potentially influencing drug development strategies, regulatory harmonisation efforts, and the overall conduct of international clinical trials.
Precision for Medicine established a legal entity in South Korea in July 2023. This provided a base for our staff with expertise in clinical operations, including site management and monitoring, and in regulatory submissions, consultations, and reporting.
Factors that make South Korea an attractive destination for conducting clinical research include
With a population of 51.6 million and a GDP of 1740.9 billion USD (11th globally in 2022), South Korea boasts the world’s top-ranked health care system.4
| 12th biggest country in the global pharma market5 | 3 weeks (on average) for IRB Submission to Approval4 |
| 97% of the population is covered by National Health Insurance3 | 30 working days needed from MFDS-CTA application to approval4 |
| TOP 5 country globally for conducting clinical trials5 | 200+ medical institutions designated by the MFDS as qualified clinical trial sites5 |
| #1 ranked city (Seoul) for number of clinical trials per city since 20175 | 26 dedicated Phase I research units5 |
| Zero OAIs (Official Action Indicated) from FDA inspection (~2008-2022) 5 | >714 research beds5 |
The South Korean Government has fully-certified around 200 clinical trial sites, with about half of these in Seoul and surrounding districts.
|
Over the last few decades, sponsors have increasingly invested in trials in South Korea, in recognition of its benefits. South Korea is particularly renown for early-phase research and oncology trials. Data depicted below shows Korea in 6th place for sponsor-initiated trials globally. In 2023, South Korea’s ranking rose to 4th place.7
The Korean pharmaceutical industry is already the 13th largest world-wide and is ramping-up R&D investments to break into international markets. These initiatives now encompass a broad range of areas, including cutting-edge new drugs, platform technologies, medical devices, healthcare IT solutions, and modified drugs. In 2016, the Korean Ministry of Food and Drug Safety (MFDS) became a member of the International Council for Harmonization (ICH). Additionally, Korea’s robust intellectual property rights protection further invigorates R&D.
The Clinical Trial Authorisation (CTA) process allows simultaneous submission of applications to the MFDS and IRBs/ ECs. After submission, the MFDS responds with either trial approval or a request for additional information within 30 working days. IRB/EC reviews are conducted through monthly meetings at the site level, typically taking about 3 weeks for approval, with expedited reviews when necessary. Recently, mutual recognition of central IRB/EC approvals across participating sites has been introduced, accelerating the review process. Overall, the review timeline for both MFDS and IRB/EC averages between 4 to 8 weeks.
South Korea has highly competitive start-up timelines compared to other major countries for clinical trials. Data published by a top 10 pharmaceutical company shows Korea ranking 6th amongst 16 top tier countries with a timeline of 112 days from the CTA package to first Site Initiation Visit.5
Clinical institutions undergo routine inspections by the MFDS and have a strong track record with audits from international regulatory bodies such as the US FDA, EMA, and PMDA. Clinical trials are internally monitored by the internal audit team in the Clinical Trials Centres for major Institutions. From October 1, 2008, to October 9, 2019, the US FDA’s CDER conducted 39 inspections in Korea, all of which resulted in no Official Actions Indicated (OAI).
All clinical trial site staff must complete a mandated number of annual training hours in GCP by the MDFS.
IRBs/ECs at major sites across Korea are accredited by international organisations like FERCAP and AAHRPP, ensuring robust oversight of human research protection.
South Korea offers compelling opportunities for sponsors thanks to an advanced medical infrastructure, streamlined regulatory processes, and high-quality research capabilities. However, capitalising on these advantages takes a partner with specialised expertise. Precision for Medicine's global capabilities provide a crucial bridge between South Korea's local strengths and international clinical research requirements.
Learn how Precision can position your development program to take advantage of emerging opportunities in Asia Pacific.