Exciting news has emerged regarding a significant reduction in the review and approval periods for medical products such as new drugs, biosimilars, and innovative medical devices. The existing review period of approximately 420 days will be shortened to 240 days. This measure is particularly aimed at enabling patients with cancer or rare diseases to access new treatments more quickly. Expectations for new therapies are likely to rise significantly from now on.

Innovations in Medical Product Approval and Review

The Ministry of Food and Drug Safety (MFDS) has established and announced the 'Innovation Plan for Medical Product Approval and Review', which will be implemented starting next month. Oh Yu-kyung, the Minister of MFDS, emphasized, "We hope this will serve as an opportunity to quickly provide treatment options to patients awaiting new drugs and those with rare diseases." This initiative is part of Korea's goal to build the world's fastest review system.

Efforts to Reduce Delays

The core of this innovation plan is to minimize factors causing delays from the preparation stage before application to the actual review phase. The MFDS plans to increase its review personnel in the bio and health sectors from the current 369 to 564, focusing on the review of critical data such as safety, efficacy, quality, and manufacturing processes. This approach aims to accelerate the review speed while simultaneously strengthening safety assessments.

• Provision of Pre-Submission Checklists: Checklists will be provided to companies to assist them in preparing their approval documentation.
• Enhanced Pre-Application Consultation: Face-to-face meetings will be conducted at least twice to allow companies to organize and submit their discussion points in advance.
• Introduction of Parallel Review: The review period will be shortened by simultaneously reviewing non-clinical, clinical, statistical, and quality data.

Hope for Patients Through Swift Reviews

The time taken from when a company submits its approval application to receiving the first request for supplementary data is expected to be significantly reduced. Previously, this took an average of 87 days for pharmaceuticals and 65 days for medical devices. However, it is now anticipated that companies will receive initial review comments within approximately 25 days. These changes will greatly enhance patient access to new treatments and reduce the uncertainty for companies from development to approval.

The MFDS explains that this innovation plan is not merely an administrative speed-up but a crucial turning point that transforms the entire approval and review system. While pursuing faster reviews, new personnel will be strategically deployed to key review areas to ensure safety assessments are not compromised. It is projected that these changes will further strengthen Korea's K-Bio competitiveness.