The Korean Food and Drug Administration (KFDA)
The KFDA oversees the safety and efficacy of drugs and medical devices in Korea. The KFDA is divided into five bureaus. The Pharmaceutical Safety Bureau and the Medical Device Safety Bureau are the two divisions holding primary responsibility for pharmaceutical and medical device regulations. In addition to its main office in Seoul, the KFDA also has six regional offices that serve as field operational bases.
The KFDA is responsible for nearly every stage in the regulatory process. It establishes safety and quality standards for pharmaceuticals and medical devices, and it oversees the approval process to ensure that new pharmaceuticals and devices conform to their standards. In order to ensure compliance, the KFDA conducts scientific testing on products submitted for approval. The Drug Evaluation Department and Medical Device Evaluation Department operate within the respective drug and device bureaus to ensure quality and standardization.
For products already on the market, KFDA regional offices carry out post-market surveillance and inspections. The Pharmaceutical and Medical Devices Research Department is responsible for evaluating product safety. The Risk Violation Central Investigation Agency performs criminal investigations and doles out punishments in the event of violations.
In addition to regulatory functions, the KFDA also develops research, study, and analysis methods for pharmaceuticals and medical devices.