The domestic approval and review period for medical products such as new drugs and biosimilars, and medical devices with new technologies, will be reduced from the current 420 days to about 240 days.
The Ministery of Food and Drug Safety (Ministery of Food and Drug Safety) said on the 26th that to enable the swift launch of safe treatments, expand treatment opportunities for the public, and strengthen K-bio competitiveness, it has prepared an "innovative plan for medical product approval and review" and will implement it starting on the 1st of next month.
With this overhaul, the number of reviewers in the bio-health sector will increase from 369 to 564.
The Ministery of Food and Drug Safety projected that by expanding staff and reorganizing the review system, it can reduce the approval and review period from the current average of 420 days to about 240 days.
The system improvements will be made across three stages: ▲ data preparation ▲ pre-application consultation ▲ post-application review.
First, to reduce companies' burden in preparing data, the Ministery of Food and Drug Safety decided to provide a checklist reflecting items that have been repeatedly pointed out during the approval and review process.
The checklist will include mandatory items to verify by major standards, such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Risk Management Plan (RMP).
Pre-application consultations, previously limited to one session, will be expanded to two or more. If a company submits prior inquiries based on the checklist, the Ministery of Food and Drug Safety will conduct a preliminary review and guide how to supplement the submission.
The Ministery of Food and Drug Safety explained, "We will remove factors causing delays before the approval application stage to improve predictability."
After an approval application is filed, the review method will also shift from sequential processing to a parallel, simultaneous review system across nonclinical, clinical, and statistical fields. To that end, with more research officers added, dedicated review teams in each field will conduct reviews simultaneously.
The Ministery of Food and Drug Safety said the time from filing to the first request for supplementation will also be significantly shortened. The period, which previously took 87 days for drugs and 65 days for medical devices, is expected to drop to about 25 days.
This overhaul follows discussions at the "2nd Core Regulation Rationalization Strategy Meeting" held in Oct. last year and chaired by President Lee Jae-myung. As a follow-up, the Ministery of Food and Drug Safety formed a task force led by Vice Minister Kim Yong-jae as Director General and has pursued system improvements.
The Ministery of Food and Drug Safety plans to brief the medical device and pharmaceutical industries on the new approval and review system on the 27th to 28th.
Oh Yu-Kyoung, head of the Ministery of Food and Drug Safety, said, "We have built a faster and more precise review system by assigning 195 new personnel to focus on reviewing safety data," and added, "We hope to offer faster treatment opportunities to patients waiting for new drugs and to people with rare diseases."
Noh Yeon-hong, head of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), said, "The industry will also raise the level of documentation and work closely with the Ministery of Food and Drug Safety so that the system innovation can take root."