With MFDS Support, Six Drugs and 42 Medical Devices Successfully Commercialized

The Ministry of Food and Drug Safety’s preconsultation program for innovative products has produced tangible results, leading to the commercialization of 48 drugs and medical devices and the entry of 62 products into clinical trials.

The National Institute of Food and Drug Safety Evaluation, under the Ministry of Food and Drug Safety, said on the 7th that it had published the “Report on the Status of Preconsultations for Innovative Products.” The report analyzes the development status of products that received consultations from August 2020, when the program began, through December 2025.

According to the report, six drugs, including two domestically developed new drugs, and 42 medical devices that underwent preconsultation received product approvals or certifications and were successfully commercialized. In addition, a total of 62 products—58 drugs and four medical devices—entered the clinical trial stage.

Notably, approximately 62% of all products advanced by at least one development stage compared with their stage at the time of the initial consultation. This indicates that the program is helping reduce uncertainty during development, including by supporting products’ transition from the nonclinical to the clinical stage.

The effect was even more pronounced for “Guide” products, which receive focused support. The proportion of Guide products that advanced by at least one stage was 75%, substantially higher than the overall average of 62%, confirming the importance of tailored support.

The number of companies receiving support through “[With-U] On-Site Preconsultation,” which involves visiting development sites in person, also rose 35% from the previous year. Industry satisfaction with the program increased 15% compared with 2021, receiving a positive assessment.

The MFDS plans to further strengthen tailored support by assigning product managers (PMs) through the “Guide Program” and linking it with the Global Innovative Fast Track (GIFT) program for expedited review.