Ahn Young-jin, Director of the Bio-Pharmaceutical Bureau at the Ministry of Food and Drug Safety, emphasized the need to establish the fastest and safest drug approval and review system in line with the era of innovative drug development utilizing artificial intelligence (AI).
Speaking at the 16th Global Healthcare Forum held at the Korea Press Center in Jung-gu, Seoul, on May 14, Ahn stated, "Reducing the development time for innovative drugs using AI will provide patients with quicker access to treatment."
He further explained that the Ministry will enhance consultations and communication with the industry to keep pace with the speed of industrial innovation and plans to shift from traditional review methods to a system that allows for simultaneous review of multiple data sets.
Ahn also introduced the Ministry's initiative to establish an 'AI Drug Review System,' stating, "We will maximize the efficiency of data review using AI and create a support system that allows companies to self-check for errors before submission."
Additionally, he announced that through the 'Global Innovative Product Fast Track (GIFT)' program, dedicated reviewers will be assigned from the early stages of development, providing one-on-one consulting to expedite the market entry of innovative products.
Ahn highlighted the Ministry's global regulatory capabilities, noting, "The Ministry has been recognized as an excellent regulatory authority by the World Health Organization (WHO) in the fields of pharmaceuticals and vaccines," and added that the 'AIRIS 2025' initiative, held last year, led efforts for global regulatory harmonization in the field of AI-utilized medical products.
He expressed hope that the forum would serve as a platform for discussions aimed at enhancing the global competitiveness of Korea's pharmaceutical and bio industries, stating, "The Ministry will actively support K-bio in seizing opportunities in the global market."
* This article has been translated by AI.
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