What Is The MFDS Process For Approving Biologics In South Korea?

The MFDS process for approving biologics in South Korea involves submitting a comprehensive application that includes preclinical and clinical trial data. The MFDS reviews safety, efficacy, and manufacturing quality. It also conducts facility inspections to ensure compliance with Good Manufacturing Practices (GMP) before granting approval, ensuring that biologics meet regulatory standards for public health.

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