The Ministery of Food and Drug Safety will streamline new drug approval and review procedures. When a drug approved as an orphan drug later undergoes a new drug approval review, some overlapping steps with what has already been reviewed will be omitted. The agency also plans to clearly refine the pre-application consultation process.
The Ministery of Food and Drug Safety said on the 31st that it revised the New Drug Item Approval and Review Work Procedures (officials' guidelines) to support rapid new drug development and launches.
The revision follows the Medical Product Approval and Review Innovation Plan released in May. The Ministery of Food and Drug Safety set a target to shorten the new drug approval period to 240 days so that safe treatments can reach patients faster, and, together with industry, operated a public-private council to develop a new drug approval and review innovation plan and prepared improvement measures.
Previously, even if a new drug developer asked the Ministery of Food and Drug Safety questions before filing an application, the consultation was a one-off and there were no official documents.
Accordingly, the Ministery of Food and Drug Safety last month introduced a Pre-NDA meeting in the stage immediately before filing, where the agency and the company discuss key matters in advance. The meeting is held twice, and the outcomes are provided as an official document to increase predictability in corporations' approval preparations.
The revised guidelines include allowing omission of certain steps that explain the overall drug—such as the Pre-NDA meeting and kickoff meeting—when a drug approved as a rare drug subsequently undergoes a new drug approval review.
The procedures for drafting and notifying the outcomes of the Pre-NDA meeting were also clarified so that corporations can reduce uncertainty during approval preparations.
The Ministery of Food and Drug Safety expects the revision to enhance the speed and transparency of the new drug approval and review process. Through this, it plans to reduce the approval preparation burden on pharmaceutical and biotech corporations and support innovative growth in Korea's biohealth industry.
An official at the Ministery of Food and Drug Safety said, "Based on thorough verification of safety and efficacy, we will push for swift approval and review of new drugs to move up people's access to treatment."