Clinical Trials for Medical Products in Korea

When medical devices are registered in Korea, foreign clinical trial data is usually accepted by the MFDS. Local clinical trials are therefore generally not required for device approval, with the exception of for certain Class IV medical devices.

The MFDS prefers foreign clinical trial data published in a professional journal. However, they will accept unpublished data as long as the studies were conducted by an acceptable research organization that followed Good Clinical Practice (GCP).

In order to submit a clinical trial application for a medical device in Korea, foreign companies must first prepare a clinical investigation plan, along with documents proving that Good Manufacturing Practice (GMP) standards are met by the foreign company’s manufacturing facility. If the device is used to treat life-threatening illnesses, a series of supplementary documents must be sent to the Investigational Review Board (IRB) for approval as well. Medical devices trials normally take only 30 days to be approved in Korea.

Electronic Filing System (KiFDA)

Korea’s clinical trial registration process – filing and submitting pre and post approval registration forms – is now online. After the medical device is approved, the e-registration system is available for applicants and CROs.

Good clinical practice in Korea (K-GCP) is aligned with international guidelines (ICH-GCP).

Adverse events must be submitted to the MFDS by manufacturers, distributors, and clinics, among others. If the incident resulted in death or life-threatening injuries, a report must be filed within seven days, with a follow-up eight days later. Events causing hospitalization, disability, or deformity must be reported within fifteen days. All other adverse events must be reported within thirty days.

After clinical trials in Korea are completed, companies should file a report to the MFDS, including all data, therapeutic effects, and adverse events from the trial.

The MFDS usually accepts foreign clinical trial data for product registration in Korea. Thus, local clinical trials in Korea for drug approval are generally not necessary.

The MFDS will accept professionally published foreign clinical trial data, as well as unpublished data that meets Good Clinical Practices (GCP).

To obtain approval for clinical trials in Korea, companies must go through the clinical trial authorization (CTA) process. Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI). Korean PIs must be well educated, trained, and have foreign language abilities. The sponsor and head of the clinical trial site will sign a written contract before the trial begins. If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.

Electronic Filing System (KiFDA)

Korea’s drug clinical trial approval forms can now be submitted through the e-registration system. Applicants and CROs can self-register their products after receiving approval.

In order to conduct the clinical trial itself, companies must execute further steps, including receiving approval from an Institutional Review Board (IRB), recruiting subjects and trial personnel, and ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs in order to determine which documents will be needed. All documents submitted by the sponsor for the clinical trial authorization (CTA) should be in Korean.