South Korea's MFDS to implement raw material certification for biopharmaceuticals

South Korea's Ministry of Food and Drug Safety (MFDS) is preparing to introduce a certification system for raw materials used in biopharmaceutical manufacturing. The initiative aims to enhance the competitiveness of the domestic Contract Development and Manufacturing Organization (CDMO) sector and reduce reliance on imports by certifying the quality and manufacturing standards of essential materials such as cell lines, cell banks, vectors, and media.

To facilitate this transition, MFDS Minister Oh Yu-kyung recently visited a manufacturer of culture media to hold a consultative meeting with both suppliers and demand-side companies. The discussion focused on practical challenges in preparing for certification and the potential for increased operational efficiency once the system is active.

The certification system is part of a broader regulatory rationalization plan aligned with the upcoming implementation of the Special Act on Regulatory Support for Biopharmaceutical CDMOs, scheduled for December 31, 2026. In preparation, the MFDS plans to publish guidelines and submission manuals in early December and will focus on training specialized personnel to ensure the stable establishment of the new regulatory framework.