Sikpum Uiyakpum Anjeoncheo reports commercialization after pre-consultations

Sikpum Uiyakpum Anjeoncheo said that innovative medicines and medical devices reached commercialization after pre-consultations, with a new report pointing to the value of sustained help for developers navigating regulatory requirements.

The agency surveyed 201 of 521 products that had received pre-consultations from the program's launch in August 2020 through December 2025. Six medicines and 42 medical devices had completed commercialization through approval, certification or other processes.

About 62 percent of surveyed products advanced by at least one stage from their initial consultation, including moves from nonclinical research to clinical trials. Pharmaceutical products for which a longer development period had elapsed after the initial consultation showed relatively higher advancement rates, the agency said, indicating that support effects accumulated over time.

Stage gains were more pronounced for products receiving focused aid under its Giljabi program, which the agency said helped resolve regulatory uncertainty and encourage follow-on development. Since 2025, the program has selected 36 products with high commercialization potential or social urgency for regular consultations. The agency plans to assign each product a dedicated manager and provide advice on development stages, clinical design and approval materials, as well as links to the GIFT expedited-review program.

Its on-site With-U consultations for regional developers and companies expanded to R&D organizations, regional development special zones, research-focused hospitals and clinical trial institutions as demand grew. The number of companies supported rose 35 percent from the previous year, while quarterly satisfaction survey results were up 15 percent from 2021.

The agency said it would continue providing "tailored pre-consultations and intensive support" that reflect researchers' and companies' needs.