Pharmaceutical/Drug Registration in Korea

The pharmaceutical/drug market in Korea is about $10.3 billion. The Korea Food and Drug Administration (KFDA) regulates pharmaceuticals/drugs in Korea. The KFDA will review the submitted documents, ask for any supplemental information and give the approval to the applicant. The application process is electronic.

The KFDA will review information such as the development history of the product, clinical reports, manufacturing, specifications and test methods, and the drug master file to ensure the safety and efficacy of the product. In certain cases, the KFDA may also ask for a local certified Korean laboratory to conduct testing on the pharmaceutical/drug product.

PBM can act as an In-Country Caretaker (ICC) and register the foreign pharmaceutical/drug company's products in their own name.

For more information on pharmaceutical/drug registration in Korea, please see the following PBM publications and/or contact us to discuss your specific needs.

Key Asian Medical Regulatory Issues