Korea's Drug Approval Process Reduced to 240 Days to Boost K-Bio Competitiveness

By Park boram Posted : July 16, 2026, 17:32 Updated : July 16, 2026, 17:32

The Ministry of Food and Drug Safety has reduced the drug approval and review period from 420 days to 240 days, establishing a world-class rapid review system.

During a report on the second half of the year held at the Blue House on July 16, the ministry presented its key achievements from the first half of the year and plans for the upcoming months.

The ministry achieved its goal of reducing the drug approval and review period to 240 days ahead of schedule, initially set for the fourth quarter of this year. Additionally, it has focused on ensuring food and drug safety in line with consumer trends, including popular K-culture tourism sites and social media products.

The ministry also reported progress in global regulatory cooperation, expanding the foundation for the overseas market entry of K-medical products and K-food through the designation of the United Arab Emirates as a reference country for pharmaceuticals and the signing of a comprehensive registration agreement for Korean and Chinese food exporters. Furthermore, it has engaged with the public through site visits and policy discussions to gather opinions and identify key safety tasks.

Building on these achievements, the ministry plans to accelerate follow-up tasks centered on safety policies that the public can feel in the second half of the year.

To ensure consumer rights and health protection, the ministry will expand the labeling requirements for genetically modified (GMO) foods to include those without GMO residues and will publicly disclose the results of harmful substance analyses in tobacco for the first time in the country.

Support for enhancing the global competitiveness of K-food, K-beauty, and K-bio will also be expanded. The ministry plans to establish a public halal certification system for food and operate a consultative body for global cosmetics regulatory authorities, as well as develop a regulatory support system for contract development and manufacturing organizations (CDMO) in biopharmaceuticals.

Additionally, to increase treatment opportunities for patients with rare and intractable diseases, the ministry will expand the emergency import of essential medical products and rationalize the approval requirements for rare drugs and follow-on products with the same ingredients.

Artificial intelligence (AI) will be actively utilized in food safety management. The ministry plans to introduce AI import food inspectors, AI foreign substance investigators, and an AI overseas direct purchase app, while providing real-time food safety information through digital platforms like FoodQR.

The ministry will also pursue regulatory improvements to prevent consumer confusion and misrepresentation. It will revise regulations related to the labeling and formulation of foods that use names or forms similar to pharmaceuticals and will establish a dedicated organization to eradicate various unfair practices in food advertising, including those involving AI.

To combat the misuse and illegal distribution of medical narcotics, the ministry will introduce punitive fines and establish a comprehensive monitoring system for narcotics misuse (K-NASS), enhancing the surveillance framework. Plans are also in place to improve the response system from prevention to rehabilitation.

Additionally, during the World Heritage Committee meeting in Busan starting July 19, the ministry will operate a food safety management team and activate a rapid response system for foodborne illnesses, ensuring thorough food safety management during the summer.

Oh Yu-kyung, head of the Ministry of Food and Drug Safety, stated, "The second half of the year will be a turning point for innovation in food and drug safety management, integrating AI and digital technology. We will prioritize public safety while further strengthening global cooperation."



* This article has been translated by AI.

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