Korea Drug Registration and Approval
The Korean pharmaceutical market is about $10.3 billion. To be successful, an excellent Korea drug regulation strategy is needed.
The Korea Food and Drug Administration (KFDA) is responsible for regulating drugs. Under the KFDA are various departments, such as the Pharmaceutical Safety Bureau (which is responsible for developing safety plans) and the Safety Evaluations Office (which is responsible for controlling the safety standards).
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 product. The application process is electronic.
For more information on Korea drug registration issues, please see the following PBM publications and/or contact us to discuss your specific needs.
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