Korea shortens drug approval process by 4 months, raises fees to align with global standards

The Ministry of Food and Drug Safety announced that it will establish a consultation department and shorten the new drug approval process by 4 months, starting this year, to focus on supporting innovation in new drug development and commercialization by domestic pharmaceutical companies and research institutions. The goal is to reduce unnecessary supplementary processes in the approval process, as well as the time companies and institutions spend preparing documents.

However, to recruit the necessary personnel and introduce systems, the fee has been raised approximately 50 times from the previous 8.83 million won to 410 million won.

On the 17th, Choi Young-joo, head of the Bio-Pharmaceutical Review Division of the Food and Drug Safety Evaluation Institute under the ministry, said at a briefing on strengthening the approval and review capabilities for biopharmaceuticals in 2025 held at the ST Center in gangnam, Seoul, "We have increased the new drug approval fees to align with those of foreign regulatory agencies, but we plan to simplify the review and approval processes by recruiting high-capacity personnel accordingly," and added, "We will elevate the new drug approval review capabilities and review system to the standards of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)."

Earlier, the ministry announced guidelines for reducing the new drug approval process at the end of last year. The core of the plan is to reduce the time taken for new drug approval reviews from the current 420 days to at least 290 days, or approximately 4 months. In particular, the period for the investigation of Good Manufacturing Practices (GMP) will be significantly reduced from a maximum of 12 months to within 90 days.

The fees pharmaceutical companies and research institutions are required to pay for new drug approvals will also increase from the previous 8.83 million won to a maximum of 410 million won. The ministry explained that the fee increase was based on the fact that the FDA's new drug approval fee is 5.3 billion won and the European Medicines Agency (EMA) charges around 490 million won.

Last month, Eli Lilly in the U.S. submitted an application for the approval of the breast cancer treatment Imruhestrant, marking the first case to apply the ministry's revised fast-track review system. Attention is focused on this case as the company paid the increased fee and submitted the application through consultations with a dedicated team.

Research Institute Jo Chang-hee noted, "From the pre-consultation stage, we will form dedicated teams for each product to ensure a smooth approval process" and added, "There are cases where companies take nearly a year to prepare documents, and we can help reduce that time."

The pre-consultation targets include treatments for serious and rare diseases, infectious disease vaccines and therapies, advanced biopharmaceuticals, and innovative medical devices. This includes specialized consultations at each stage of the clinical trial plan (IND) from the non-clinical design stage. The ministry is also expected to launch a visit-based approval support service called 'Approval On' soon.

The ministry expects to see effects in supporting the development of domestic innovative biopharmaceuticals through this fast-track review system reform. Kim Young-joo, head of the Drug Approval Coordination Division, stated, "Each new drug approved can increase annual sales by 4 billion to 5 billion won, so even a month’s reduction in the approval timeline more than compensates for the fee of 410 million won."