Updated on 13 September 2013
The South Korean government has implemented new policies giving tax breaks for research and development costs and established a research and development (R&D) fund for the pharmaceutical market. The government also promotes pharmaceutical mergers and acquisitions, and trains workers in the industry. News coverage continues to announce the expansion of Big Pharma into South Korea, highlighting new research and development centers, partnerships, and preferred provider status of domestic Korean clinical research organizations (CROs), while global clinical research organizations are further developing market access and domestic partnerships.
Last year, South Korea was listed as eighth in the world based upon the value of their pharma transactions, ahead of countries such as Japan, Switzerland, and the United Kingdom, according to a report by IMAP Healthcare.
Clinical trial environment
As South Korea continues to adopt a more western way of life, lifestyle-related diseases such as obesity, cardiovascular disease, diabetes, and osteoporosis are on the rise. Furthermore, the fact that most hospitals have clinical trial centers provides a convenient one-stop-shop for clinical trials, including study coordinators, training for investigators, dedicated pharmacy and pharmacists, archiving facilities, and dedicated monitoring rooms. Nearly all Korean investigators are well-versed in English. They can read and write the language without difficulty. Standard operating procedures (SOPs), case report forms (CRFs), and monitoring reports are all written in English.
The need for more clinical research professionals was noted as a challenge to conducting trials in South Korea. Due to the growth of clinical research in Korea, investigators and experienced study coordinators are in high demand. Investigational New Drug trials are only conducted in Korean FDA- ertified clinical trial institutions (mostly general hospitals) where physicians are busy with patient care and it can be challenging to find investigators who can allocate enough time to clinical trials. Korea National Enterprise for Clinical Trials (KoNECT) currently supports various education programs for clinical research associates (CRAs), clinical investigators, study coordinators, clinical pharmacologists etc to help meet the growing market demand. The regulatory requirements in Korea are similar to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries.