국가임상시험지원재단

These regulatory reform efforts are ongoing and Ministry of Food and Drug Safety(MFDS) announced the '5-yearcomprehensive plans for clinical trial development' in2019 to become the patient-centered new drug developing powerhouse. The plans include facilitating preliminary IND review system to foster early phase studies. Once safety data confirmed through this pre-review meeting, approval timeline may be shortened(30days->7days) The IRB approval process typically occurs in parallel to an MFDS review, with busy sites holding IRB meetings on a weekly basis.

Korea’s public healthcare system also ensures reimbursement for most medical expenses, such that an estimated 97% of the 51 million population benefits from healthcare coverage via the national insurance system.

Major university hospitals are generally larger than 1,000 beds and receive as many as 10,000 or more outpatients a day. Designated clinical trial centers (CTCs) affiliated with these hospitals have access to a large and diverse patient pool and benefit from rapid patient recruitment. Accordingly, Korean CTCs are widely recognized as among the fastest patient recruitment sites in the world, and boast relatively low drop-out rates during the conduct of clinical trials.

Korea’s CTCs are home to world-class facilities and infrastructure, while an outstanding oversight of quality control, staff management and development ensures the successful conduct of patient as well as healthy volunteer clinical trials.

Furthermore, there are over 170 clinical trial sites inspected and certified by the Korea Ministry of Food and Drug Safety (MFDS, formerly KFDA). According to the US FDA, which has conducted due diligence in Korea since 2008, Korea maintains a perfect record with no major official actions recorded for any clinical or non-clinical trials.

Last but not least, Korean investigators regularly receive intensive GCP training in these major hospitals nationwide.