New drug review timeline cut from 295 to 240 days

MFDS to formalize pre-submission face-to-face meetings… introduces checklist system

As the Ministry of Food and Drug Safety (MFDS) moves to shorten new drug approval review timelines from 295 days to 240 days while strengthening communication with companies. The agency will introduce face-to-face meetings between companies and reviewers prior to the application stage, as well as a “checklist” for companies to self-review their data, aiming to reduce the total approval period by nearly 2 months compared to the previous process.

The MFDS announced that it has prepared a revised draft of the “New Drug Product Approval and Review Procedures (Civil Servant Guidelines),” which is currently undergoing a public comment period, and plans to fully implement it starting October 1. This revision, coming approximately one and a half years after the guidelines were established in December 2024, was pursued to maximize the predictability of new drug approvals.

From post-submission to pre-submission… introduction of advance face-to-face meetings

The most significant change is the introduction of ‘pre-NDA meetings.’ Under the original 2024 version, a dedicated team was formed and the review began within 10 days of receiving the application; however, the revised version requires the company and the MFDS to begin discussions 3 months prior to application submission.

When a company requests a face-to-face meeting, a dedicated team is formed immediately, and through at least 2 meetings, any deficiencies in the data will be identified in advance. This is expected to serve as a key mechanism to accelerate the entire process by reducing the time spent on ‘requests for additional information,’ which frequently occur during the official review stage.

AI-generated graphic image

Introducing a ‘checklist’ to prevent ‘insufficient data’ at the source

The ‘checklist’ system, which requires companies to self-verify the completeness of their submitted data, is another key change in this amendment. Previously, the MFDS would notify companies of required corrections on a case-by-case basis after receiving the data; now, companies must complete a self-inspection using a detailed checklist starting from the face-to-face meeting stage prior to application.

Products that undergo this procedure will see a significant reduction in errors or omissions in their documentation, resulting in the “preliminary review” period, conducted immediately after submission, being shortened from the previous 7 days to within 3 days.

Approval timeline shortened by 55 days… “295 Days → 240 Days”

Through these strengthened communication systems, the Ministry of Food and Drug Safety (MFDS) has set the target approval period for new drugs at 240 days, down from the previous 295 days. This represents a reduction of approximately 55 days compared to the original regulations.

In addition, the govenrment has maximized review efficiency by codifying a ‘rolling review’ procedure for frequent exchange of opinions during the review process and by moving the GCP (Good Clinical Practice) site inspection, which previously took place after the first round of supplementary submissions, to the early stages of the review (within 60 to 120 days after submission).

An MFDS official stated, “This revision goes beyond simply shortening the timeline; it institutionalizes ‘pre-submission communication’ and ‘self-assessment by companies’ to overcome the limitations identified during the operation of the original version. Once the new procedures take effect this coming October, the speed at which innovative new drugs enter the market, both domestically and internationally, will increase dramatically.”

The industry’s response has also been favorable. An official from the Korea Biomedicine Industry Association said, “The introduction of the checklist will help ensure that more comprehensive data is submitted when applying for new drug approval and will likely reduce the need for supplementary data in the future. This is interpreted as a positive gesture where the MFDS and companies join hands to successfully complete the product approval process.”