Buoyed by Qarziba’s success, MFDS expands support for innovative drugs

The Ministry of Food and Drug Safety (MFDS) will significantly strengthen support for developing innovative products, such as new drugs, advanced biopharmaceuticals, and innovative medical devices.

At a news conference on Tuesday, the National Institute of Food and Drug Safety Evaluation (NIFDS) under the ministry unveiled plans to strengthen support for developing innovative products, including new drugs, advanced biopharmaceuticals, and innovative medical devices.

The support expansion is based on the rapid approval and reimbursement of rare disease treatments, including Qarziba (dinutuximab beta), a neuroblastoma drug.

Specifically, MFDS will introduce the “GILJABI” (Guiding Insight to Lead the Journey toward Advanced and Breakthrough Innovative Products) system to accelerate the commercialization of innovative products. The program will provide preliminary counseling to researchers and companies developing innovative products to guide them on the right path from development to approval.

Starting this June, it will select 20 items to provide full-cycle support from product development to approval.

“Among the 500 items that have been pre-consulted so far, we will prioritize those that are urgent and important to society,” said Kim Hee-seong, director of the Pre-consultation Division at NIFDS’s Commercialization Strategy Support Team. “We will focus on new technologies and concepts, rare and incurable diseases, and treatments for severe diseases.”

Regarding the selection criteria, Kim said, “We will focus on companies with a lot of current data, specific development plans, and the will to commercialize their products. To ensure the objectivity of the selection, we will launch a selection committee in May composed of external experts from academia and industry.”

To introduce the program, NIFDS held the “Meeting to Support the Development and Commercialization of New and Conceptual Global Medicines in 2025” at the Korea Press Center on Thursday last week and confirmed the industry’s high expectations.

“Some companies have expressed their desire to be selected, saying that their executives have a special interest in them,” Director Kim said. “We would like to support many companies. However, due to the limitations of our organization and manpower, we plan to start with 20 items and gradually expand as we see the program's effectiveness.”

GIFT system’s results become visible to expand the provision of information to patients

GIFT (Global Innovative Product Fast Track), an expedited review system introduced by the MFDS in 2021, also shows tangible results.

“Previously, only the status of GIFT-designated items was disclosed on the website. In the future, however, we will provide information, such as the mechanism of action, clinical information, side effects, and others, in an easy-to-understand manner for patients along with the time of approval,” said Park Jae-hyun, director of the Rapid Review Division in the NIFDS’ Innovative Product Review Team.

This year, the institute will also start the “HOPE Forum” and operate it as a symposium. “It will be a place to share the development status and screening results of newly developed rare disease drugs and GIFT-designated items and listen to patients' opinions,” Park explained.

The MFDS operates the GIFT program with the Ministry of Health and Welfare's “Parallel Pilot Project for Approval, Salary Evaluation, and Drug Price Negotiation.”

“The GIFT-related items were selected for the pilot project because other ministries agreed with the purpose of the GIFT to supply drugs for severe and incurable diseases to patients quickly,” Park noted.

If the Ministry of Health and Welfare's “Permission and Benefits Evaluation System” started evaluating health insurance benefits after completing safety and efficacy evaluations, the current pilot project links GIFT with the system, sharing information in real-time with the Health Insurance Review and Evaluation Service (HIRA) and the National Health Insurance Service (NHIS) from the permit review stage and negotiating drug prices.

As a result, Qarziba, which was selected for the first pilot project, was covered by insurance within six months of its approval last year.

“The second pilot project (currently underway) has even closer inter-ministerial cooperation than the first,” Park said. “Better results are expected with regular quarterly inspections and real-time progress sharing.”

Asked if the MFDS is considering charging a fee for the GIFT system amid the recent increase in the drug approval fee, Park said, “Currently, we do not charge a separate fee for GIFT designation or expedited review. However, we are considering it (whether to charge a fee),” Park said. “We are examining the fee system with the policymaking and approval departments and plan to collect the industry’s opinions.”

‘One-stop support for vaccine development and export using the Hwasun Center’

The MFDS has also introduced a new vaccine development program called “BOOST (Building of Outcomes with Support Team).”

BOOST is a triangular cooperation system between MFDS, the Hwasun Vaccine Safety and Technology Support Center, and the Korea Biomedicine Industry Association (KoBIA). The MFDS provides non-clinical and clinical consultation, the Hwasun Vaccine Safety and Technology Support Center provides GMP and quality control consultation, and the KoBIA provides export-related information.

Explaining why the BOOST program operates separately from other support systems, Director Kim said, “Pre-consultations on post-Covid-19 vaccines make up a significant portion of the total consultations, but actual development progress is slow.”

Due to their nature of development, vaccines require specialized expertise in GMP (manufacturing quality control standards), raw materials, and quality control. Therefore, the government decided that customized support that uses the expertise of each institution would be effective, she explained.

“Through the Hwasun Center, infectious disease prevention vaccine development companies aiming for domestic self-sufficiency or overseas expansion can receive one-stop support from the three institutions, which will help them improve the success rate of vaccine development and accelerate their global expansion,” Kim added.