Clinical Trials for Medical Products in Korea

clinical trials in KoreaWith its high quality clinical research infrastructure and diverse population, Korea is now one of the top destinations for clinical trials. The Korean government has established key partnerships with some large multinational Contract Research Organizations (CROs) based in Korea. The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA), is the agency that regulates the safety and efficacy of medical devices and drugs within Korea.

In recent years, Korea has implemented safety and protection requirements for participants in drug clinical trials, such as compensation, as well as MFDS-enforced training programs for professionals involved in clinical trial operations. Korea is also working on improving technology innovation guidelines for clinical trials, from risk monitoring to statistical analysis and data managing practices.

To help you take advantage of this advantageous clinical research landscape in Korea, Pacific Bridge Medical offers comprehensive clinical trials management and consulting services. Our experienced professionals can oversee your clinical trial process locally and meet with the relevant regulatory authorities on your behalf to ensure that the trials are conducted in the most efficient and cost-effective manner.

Please click on the questions below to find out more details about the regulatory requirements for clinical trials in Korea.

Clinical Trials for Medical Devices in Korea

Are local clinical trials required for product registration?

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 However, they will accept unpublished data as long as the studies were conducted by an acceptable research organization that followed Good Clinical Practice (GCP).

What are the requirements to obtain approval for clinical trial initiation?

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.

What are the requirements for conducting clinical trials?

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.

Clinical Trials for Pharmaceuticals in Korea

Are local clinical trials required for product registration?

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).

What are the requirements to obtain approval for clinical trial initiation?

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.

What are the requirements for conducting clinical trials?

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.

If you are considering conducting clinical trials in Korea, contact us today to discuss your needs with our Korea experts.

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