Faster Approval for New Drugs and Biosimilars... Speed Innovation Through Simultaneous and Parallel Review

MFDS to Implement Innovative Process for New Medical Devices from June
195 New Reviewers to Be Hired; "Continuous Review and Supplementary Feedback" to Be Provided

An innovative process aimed at drastically shortening the approval and review period for new drugs in Korea to around 240 days is being implemented, enabling them to be rapidly released. The intention is to ensure that patients in Korea have the fastest possible access to treatment opportunities worldwide.

The Ministry of Food and Drug Safety announced on May 26 that it has established the "Medical Product Approval and Review Innovation Measures," which focus on the expedited approval of new drugs, biosimilars, and innovative medical devices, and that the related guidelines will take effect starting June 1. This is a follow-up measure to the "Second Core Regulatory Rationalization Strategy Meeting" presided over by the President in October last year.

The Ministry will first hire 195 new reviewers and move away from its traditional sequential review process by forming dedicated review teams for each field to examine materials concurrently, introducing a "continuous review, supplement, and submission system." Previously, limited staff had to meticulously review vast amounts of data from start to finish, and only after the drug approval application was accepted did the agency notify companies of supplementary requirements after 87 days (or 65 days for medical devices). As a result, companies had to spend considerable time just preparing the required supplementary data.

From now on, however, companies will receive the first review opinions on quality, safety and efficacy, and other areas by the 25th day after submission. This will allow companies to quickly identify the required supplements and prepare and submit the necessary materials, greatly reducing the overall approval period.

Efforts are also being made to reduce trial and error even before the application is submitted. In the past, companies prepared approval and review materials on their own, and depending on their experience or understanding of the relevant regulations, they often had difficulties or omitted important items. If the approval documents were insufficient, additional supplements would be required, and the time needed to redo the documents would delay the approval process.

To address this, the Ministry will distribute a checklist containing essential items that companies can use to self-assess the completeness of their materials throughout the entire product development cycle. The checklist includes frequently supplemented items at the time of application, items that typically take a long time to prepare upon request, and other critical elements that must be confirmed before submitting approval and review applications, such as safety and efficacy, quality, manufacturing and quality control (GMP), clinical trials (GCP), and risk management plans (RMP).

Additionally, a "pre-approval meeting (Pre-NDA Meeting)" will be introduced, whereby companies and the Ministry will hold at least two official meetings before submitting an application. This will help to resolve potential delays in advance and improve the predictability of the review process.

Oh Yoo-kyung, Commissioner of the Ministry of Food and Drug Safety, stated, "The 195 new staff members secured in the first phase will be assigned to review safety-related documents and other critical materials, allowing us to establish a more thorough and expedited approval and review system. Through this innovation, we hope to provide patients waiting for new drugs with treatment opportunities faster than anywhere else in the world."

Patient groups and the pharmaceutical industry have also expressed high expectations. Ahn Ki-jong, President of the Korea Patient Organization Alliance, said, "For patients in urgent need of treatment, the time until new drug approval is extremely important. We hope that this innovation in approval and review will allow patients to receive the necessary treatments more quickly and return to their daily lives as soon as possible."

No Yeon-hong, President of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, commented, "This measure is not just about speeding up the process but is an innovation that will fundamentally change the approval and review system. It will serve as a new catalyst for the development of our pharmaceutical industry."

This content was produced with the assistance of AI translation services.