What Are The MFDS Guidelines For Registering Biosimilars?

The Ministry of Food and Drug Safety (MFDS) in South Korea requires biosimilar registration to follow guidelines that ensure quality, safety, and efficacy. Applicants must submit comparative data on analytical, non-clinical, and clinical aspects against the reference biologic. Additionally, they must meet Good Manufacturing Practice (GMP) standards and perform post-marketing surveillance.

Leave a Reply

You must be logged in to post a comment.