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Fast Facts

  • Capital: Seoul
  • Economy: Nominal: US$1.41 trillion, 2014
  • Health Expenditure: South Korea 7.2% of GDP, 2013
  • Population: 51.48 million, 2015
  • Average Life Span: South Korea 78/85 (m/f), 2013
  • Languages: Korean
  • Adult Literacy Rate: 97.9% 2014

Health Trends

  • The South Korean pharmaceutical market was expected to climb in value from $19.3 billion in 2013 to $24.3 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 3.9% projected by research and consulting firm Global Data.
  • The performance of the market is forecast to accelerate, with an anticipated CAGR of 8.9% for the five-year period 2010-2015, which is expected to drive the market to a value of $19.3 billion by the end of 2015.
  • 3rd largest pharmaceutical market after Japan and China in the region and continues to grow in double digits since 2002. 
  • The number of people enrolled in the National Health Insurance Program is 28,445,033 (57.7%) Employee Insured and 18,964,567 (38.6%) Self-employed. This drives patients to look for medical treatment and increases good patient pools for clinical trials.
  • South Korea has an universal health insurance system that is compulsory and covers employees and their relatives via NHI. 
  • Patient pools centralised in big university hospitals mainly located in Seoul thus, excellent representation of patients in university hospital regardless of disease incidence rate. 
  • Central governance system is put in place mandated by MFDS to ensure quality of healthcare professionals engaged in clinical research - Mandatory training on clinical trial essentials is required by staffs involved in conduct of clinical trials (e.g. investigators, study coordinators, CRAs, etc.). 
  • The biologic sector is witnessing rapid growth, and many local companies expanded their operations in 2011. Several significant biologic joint-ventures were completed in 2011.
  • The leading cause of death is cancer, followed by cerebrovascular and heart disease.
  • The most prevalent cancers in Korea are stomach, colorectal, lung and liver in men and thyroid, breast, stomach and colon in women.


Clinical Trial Landscape

  • The Korean Regulatory Authority has changed its name from the Korea Food and Drug Administration (KFDA) to the Ministry of Food & Drug Safety (MFDS) in Mar 2013 with the upgrade in governance structure to offer better oversight of the food and drug regulatory system.
  • Adapted ICH-GCP in 2000 and implementing KGCP since 2001.
  • Government invested USD$60 million to establish 15 regional clinical trial centres to support the clinical trial activities in the region to encourage more sponsored clinical trials and to strengthen Korea’s position as an Asian biotech hub.
  • Korea has ranked as the 10th country across the globe in the number of sponsored initiated trials (SIT) since 2010 and ranked as high as the 7th in 2014 based on the information from www,
  • Seoul (Korean capital) has ranked as no. 1 city in the number of SIT since 2011 based on the information from 
  • Most hospitals have clinical trial centres, one stop clinical trial support and dedicated supports for clinical trials including study coordinator, continuous training for investigators, dedicated pharmacy and pharmacist, archiving facilities, dedicated monitoring rooms etc.
  • Start-up cycle times in Korea are the most competitive not only within the Asia Pacific region but compared to global scale as well being one of the fastest countries to initiate investigator sites to enrol patients.
  • Regulatory approval process (if no comment) takes 4 weeks. IRB meeting held bi-weekly in most investigator centres and English version of sponsor’s contract template is acceptable. 
  • Regulatory requirements and review process is well defined.

ICON in Korea

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  • Presence in Korea since 2005
  • Leading office for clinical trials in ICON Asia
  • Mainly clinical operation service
  • Managing 94 protocols including the following therapeutic areas:
    • Oncology: NSCLC, Breast, Hepatocellular, Colorectal, Gastric, Prostate, Cervical, Multiple Myeloma, Chronic Leukaemia, Lymphoma, NHL, Astrocytoma,
    • Endocrinology: DM, Growth Hormone
    • Deficiency, Infection: Hep B, Hep C, Pneumonia, Skin Infection
    • Blood system disorder: Anemia, Myelo-dysplastic syndrome
    • Musculoskeletal disease: Osteoarthritis
    • Internal Medicine: Ulcerative Colitis, SUI,
    • Pulmonary: COPD, Asthma, Idiopathic pulmonary fibrosis
    • Cardiology: ACS, VTE, Atrial Fibrillation
    • Surgical and medical procedures: Kidney Transplant
    • Neuroscience: Alzheimer Disease, Major Depressive Disorder, ADHD.
  • 1 KFDA inspection for site and 1 KFDA inspection for ICON clinical operation in Korea: no issue from two inspections proves good quality service
  • ISO certified office in 2009

Services Offered

  • Project Management
  • Study Start-up
  • Clinical Monitoring
  • Medical & Safety Services
  • Quality Assurance
  • Bio Statistics
  • DOCS Resourcing Solutions:
    • Functional Resourcing 
    • Flexible Resourcing
    • Permanent Recruitment 

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