The Ministery of Food and Drug Safety will overhaul the food and drug safety management system by using artificial intelligence (AI) and digital technologies, and raise the speed of approvals and reviews for medical products to the world's fastest level. It will tighten monitoring of abuse and misuse of medical narcotics and expand direct government supply of rare and essential medical products.
The Ministery of Food and Drug Safety on the 16th unveiled key tasks for 2026 at a briefing at the Sejong Convention Center, including AI-based food safety management, blocking illegal and false advertising, integrated monitoring of medical narcotics, and innovation in approvals and reviews for medical products.
Regulations on illegal and false advertising will be significantly toughened. Ads featuring AI-generated fake doctors or pharmacists recommending food or drugs will be clearly banned, and the entities producing ads about cosmetic efficacy and quality will be limited to responsible sales companies. Online, an AI-based monitoring system will detect illegal distribution of medical narcotics and pharmaceuticals in real time, and urgent issues will be blocked first and reviewed later. Among general foods in tablet or capsule form, products likely to be mistaken for drugs or health functional foods will face restrictions on production, labeling, and advertising.
Management of medical narcotics will also be further strengthened. The Ministery of Food and Drug Safety will build an "integrated monitoring system for abuse and misuse of narcotics" that integrates information from related ministries and analyzes it with AI, and will gradually expand the list of ingredients requiring a pre-prescription medication history check and the scope of bans on self-prescribing by medical professionals. The designation period for temporary narcotics will be shortened, and a legal basis will be established for preemptive designation before new substances are distributed. To prevent addiction and support rehabilitation, prevention activities for college students and young people and rehabilitation support for people with addiction will be expanded.
Stabilizing the supply of medical products was also presented as a key task. For treatments for rare and intractable diseases and essential medical products, direct government supply and emergency introduction will be expanded, and a predictive model linked to pharmaceutical supply and demand data will be used to manage supply instability in advance. For self-treatment medical devices imported directly by patients, some submission documents will be exempted upon reimport.
In industry, innovation in approvals and reviews for medical products is the priority. The Ministery of Food and Drug Safety said it plans to shorten approval periods for new drugs, biosimilars, and medical devices to around 240 days through in-depth preliminary reviews, parallel reviews, and dedicated review teams. It will introduce an AI-based approval and review support system to assist with summarizing and translating submitted materials and drafting review reports, and rationalize approval requirements with risk-based regulation. For Generative AI medical devices and digitally converged pharmaceuticals, it will establish tailored approval and review standards to support market entry of new-technology products.
It also plans to strengthen export-oriented regulatory support and international cooperation for overseas expansion of biopharmaceuticals, cosmetics, and foods, and to work to remove non-tariff barriers by leading global regulatory standards.
In food, an AI risk prediction system will be introduced to selectively inspect imported foods with high safety concerns, and an AI foreign matter detector will be developed to improve accuracy in detecting foreign matter such as injection needles and suppuration in meat. Predictive models for major food hazards such as salmonella will be built to establish a preemptive blocking system. Smart HACCP, which manages processes in real time from manufacturing to distribution, will be expanded, and management of intentional food fraud will be strengthened through global HACCP.