Rapid Supply of Biopharmaceuticals Facing Shortages Through Expedited Review

MFDS Revises Regulations on Product Approval and Review of Biological Products

The Ministry of Food and Drug Safety announced on November 12 that it will revise and implement the "Regulations on Product Approval and Review of Biological Products" and the "Regulations on Product Approval and Review of Advanced Biopharmaceuticals" to strengthen the establishment of a rapid review system in preparation for potential supply crises of biopharmaceuticals such as vaccines.

This revision is part of the "Top 50 Food and Drug Safety Initiatives" announced on November 5. Previously, rapid review was only available for new drugs and those that had undergone prior review, making the scope limited. However, with this amendment, the scope has been expanded to include "drugs facing supply shortage issues" that may arise during situations such as the COVID-19 pandemic.

On November 4, as part of the Top 50 Food and Drug Safety Initiatives, the Ministry also issued an administrative notice for a revision to the "Regulations on the Designation, Approval Procedures, and Methods for National Lot Release Approval of Drugs." The revision exempts drugs from national lot release approval if the manufacturing number of the primary packaging (immediate container) is the same, even if the manufacturing number of the secondary packaging is different.

The Ministry of Food and Drug Safety emphasized, "We will continue to swiftly implement regulatory improvements related to biopharmaceuticals and proactively enhance the system going forward."