The Ministry of Food and Drug Safety (MFDS) in South Korea has introduced regulatory amendments to streamline the approval process for biosimilars approval. These updates focus on enabling expedited review pathways to accelerate access to biologic drugs while maintaining standards of quality, safety, and clinical efficacy.
Under the revised “Regulations on the Approval and Review of Biological Products,” the approval timeline for biosimilars has been reduced from 406 days to 295 days, supported by enhanced administrative mechanisms for expedited review. This initiative strengthens regulatory efficiency and supports faster market entry for biologics.
The amendment also introduces a more flexible approach to manufacturing changes. For modifications with minimal impact on product quality, companies may follow pre-market or post-market (annual) reporting pathways, reducing the need for extensive regulatory review and enabling efficient lifecycle management.
Overall, these updates reinforce MFDS’s commitment to improving regulatory systems, supporting innovation, and promoting growth in the biopharmaceutical sector.
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