[Reporter’s Notebook] Lee Administration’s “New Drug Speed Race” Hinges on Detail and Execution

Bio Startups and Ventures Department Jeong Donghoon Reporter

"We are aiming to make the new drug approval period the shortest in the world, dramatically reducing the timeline,"

President Lee Jaemyung has declared a "race for speed in new drug development." This announcement was made during a forum held on September 5 at Songdo Convensia in Incheon, where he met with representatives of bio companies. This is the second time President Lee has held such a discussion with industry stakeholders, following a previous meeting with the defense industry. On this day, the Lee administration unveiled its plan to reduce the new drug approval review period from 406 days to 295 days, while also presenting ambitious goals such as achieving the world's third-largest number of clinical trials, creating three blockbuster new drugs, and doubling biopharmaceutical exports.

In the bio industry, time is money. A difference of just a few months can translate into billions of dollars in sales. For this reason, major global pharmaceutical and biotech powerhouses have been racing to implement regulatory reforms, accelerate clinical trials, and expedite approvals. Examples include the Fast Track program of the U.S. Food and Drug Administration (FDA), conditional approvals by the European Medicines Agency (EMA), and China's 30-day reduction in Investigational New Drug (IND) application review. The direction of these policies is clearly in line with global trends. For Korea, keeping up with this pace is not a choice but a necessity, making the government's recent move noteworthy.

The key now is bold execution and attention to detail. Real change for companies is ultimately felt on the ground. If the government declares a reduction in approval review periods, it must be accompanied by plans to increase the number of reviewers and provide specialized training. Furthermore, when new drug approval, reimbursement evaluation, and drug price negotiations are conducted simultaneously, there must be concrete improvements to data linkage systems and collaborative frameworks among the Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, and the Ministry of Food and Drug Safety. To ensure that the numerical targets presented translate into tangible results, such sophisticated policy design is essential.

Another crucial pillar is finance. For biotechs to advance their new drug pipelines to the clinical stage, they must invest enormous amounts of capital. However, Korea's venture capital market is currently contracting, and after listing through the technology exception system, companies often face delisting risks due to issues such as "loss from continuing operations before corporate tax." The government's proposed expansion of policy funds and financial support is an important starting point to break this cycle. However, simply declaring an increase in funds is not enough. Biotechs, whose very nature involves risk and the possibility of failure, require risk-dispersing financial models tailored to the industry. This includes joint public-private investment, differentiated support by clinical stage, enhanced tax incentives, and the capitalization of R&D expenses.

The government's mandate is clear: to shorten the timeline for innovative new drugs by realistically upgrading review and clinical infrastructure, and to design a market-friendly, sustainable financial system to ensure funding for biotechs. What companies want is not just slogans, but changes they can actually feel in the field. The bio industry is now considered a next-generation growth engine for the Korean economy. As the global market heats up with competition for innovative new drugs, what is needed most is speed and precision in policies that make a real difference on the ground.