MFDS Revises New Drug Approval Review Procedures to Increase Speed and Transparency

The Ministry of Food and Drug Safety (MFDS) is improving the approval and review procedures for new drugs to increase speed and transparency.

The MFDS said on the 31st that it had revised the civil servant guidance document, “Procedures for New Drug Product Approval and Review.” The revision is a follow-up measure to the “Innovation Plan for Medical Product Approval and Review” announced in May and aims to accelerate the launch of safe treatments.

The key change is the streamlining of procedures for approval changes when a drug first approved as an orphan drug is converted to a new drug. In such cases, some procedures, including the “Pre-NDA meeting” and kickoff meeting, may be omitted.

The revision also clearly defines the procedures for preparing and notifying participants of the results of the “Pre-NDA meeting.” The measure is intended to improve pharmaceutical companies’ predictability regarding approval and review.

The MFDS said it had closely consulted with the industry while operating a public-private consultative body to develop the “Innovation Plan for New Drug Approval and Review.”

The MFDS said, “Through this revision of the guidance document, we will drive innovative growth in Korea’s biohealth industry and bring forward patients’ opportunities for treatment by expediting the approval and review of new drugs.”