The Ministry of Food and Drug Safety (MFDS) (Image courtesy of Yonhap)
SEOUL, Jan. 2 (Korea Bizwire) — The Ministry of Food and Drug Safety (MFDS) announced significant reforms to streamline drug approval processes in 2025, including reducing the time required for registering imported active pharmaceutical ingredients (APIs) and simplifying compliance procedures for low-risk manufacturers.
A dedicated task force will now handle new drug approvals, increasing company consultations and reviews from three to as many as ten sessions. The new process includes conducting Good Manufacturing Practice (GMP) evaluations within 90 days of submission, ensuring faster approval timelines.
Faster Drug Approvals and Revised Fees
MFDS aims to complete the entire approval process for new drugs, from application to certification, within 295 days. To support these innovations, a restructured application fee of 410 million KRW for new drug approvals will take effect starting February 1, 2025.
“This fee was determined after extensive discussions with the pharmaceutical industry, and it reflects the resources required for a faster, more transparent, and predictable approval process,” said an MFDS spokesperson.
The ministry also plans to raise fees for general pharmaceutical products over time to further support regulatory improvements.
Simplified GMP Evaluations
GMP compliance assessments for drug approvals will also be overhauled. Key changes include:
- Reducing the registration period for imported APIs from 120 days to 20 days.
- Consolidating required documentation for GMP evaluations from 11 types to just four.
- Allowing low-risk manufacturers to extend GMP certifications through a simplified paper-based review, rather than the current mandatory on-site inspections, provided no significant changes have occurred.
These adjustments are designed to enhance efficiency and focus regulatory resources on higher-risk facilities.
Industry Briefings and Implementation
The MFDS will host industry briefings in the first half of 2025 to outline specific measures and implementation plans for these reforms. Full-scale adoption is scheduled for the second half of the year.
These changes aim to foster innovation in South Korea’s pharmaceutical sector by expediting new drug approvals while maintaining rigorous safety and quality standards, ensuring faster access to medicines for patients.
M. H. Lee (mhlee@koreabizwire.com)
