The Ministry of Food and Drug Safety (MFDS) is stepping up direct support for developers of advanced biopharmaceuticals, introducing a system of dedicated regulatory consultants and expanded pre-consultation services.
The National Institute of Food and Drug Safety Evaluation (NIFDS), under the MFDS, outlined the initiative at a press briefing Tuesday in Osong, introducing a new regulatory support program aimed at facilitating commercialization of advanced therapies.
Wang So-young, director of the Cell and Gene Therapy Products Division at NIFDS, speaks during a press briefing Tuesday. (Courtesy of MFDS press corps)
The program provides end-to-end consultation across the development cycle, from nonclinical research to marketing authorization, along with practical training to help companies navigate regulatory requirements.
The Cell and Gene Therapy Products Division said the pre-consultation program has been expanded to include companies at the nonclinical stage, whereas it was previously limited to those entering clinical trials.
Wang So-young, director of the division, said the government secured 1 billion won ($676,700) last year to recruit 13 regulatory consultants. Twelve are currently in place, with one additional hire planned, and they are expected to begin supporting development sites in June after completing training.
The consultants have backgrounds in pharmacy, life sciences, and biopharmaceuticals, and were selected for their expertise in approval processes, regulatory guidelines, and the Common Technical Document (CTD). They also bring hands-on experience in chemistry, manufacturing, and controls (CMC), nonclinical and clinical development, and regulatory review.
Their role will include advising companies on development strategies from a regulatory perspective and supporting data review for investigational new drug (IND) applications and marketing approvals.
With the expanded team, the institute expects to shift from general company inquiries to product-specific, tailored consultations.
“In the past, we responded to company questions,” Wang said. “Now we aim to proactively analyze each product and guide developers on approval requirements in advance.”
She added that each product will receive dedicated, one-on-one regulatory support throughout development.
The division aims to handle 300 consultation cases annually but has already received more than 300 requests. Previously, limited staffing meant only about 30 percent of requests could be addressed.
The service is available to companies, research institutions, and professionals preparing clinical trials and marketing applications for a range of advanced biopharmaceuticals, including cell and gene therapies, tissue-engineered products, and next-generation biologics.
Applications can be submitted through the MFDS website under “Pre-consultation for Innovative Products” or “Integrated Consultation Reservation.”
Kwon Min-seon
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