MFDS Enhances Support for Drug Addicts' Social Reintegration and Shortens New Drug Approval Period

The Ministry of Food and Drug Safety (MFDS) will significantly shorten the approval period for new drugs and strengthen support for the social reintegration of drug addiction patients.

2025 Major Policy Implementation Plan of the Ministry of Food and Drug Safety. Ministry of Food and Drug Safety

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On the 21st, the MFDS announced this through the "2025 MFDS Major Policy Implementation Plan." The MFDS introduced this year's policy plan centered on four core strategies: safety, consideration, growth, and innovation.

First, regarding safety, an online illegal food and drug distribution monitoring system called "AI Cops" will be introduced. Through this, illegal products will be quickly detected, and illegal activities during personal transactions on overseas shopping malls and social media (SNS) will be inspected.

Management of misuse and abuse of food and medical narcotics will also be thoroughly conducted. Specifically, safety management will be strengthened for widely consumed foods such as kimchi and processed roe products that may cause large-scale food poisoning, and the scope of patient medication history verification before medical prescriptions will be gradually expanded from fentanyl to methylphenidate and appetite suppressants.

In the area of consideration, a stable supply chain for medical products will be established. To enable rapid prediction and preparation for drug supply and demand, the reporting period for prior notification of supply suspension by drug manufacturers and importers will be advanced to 180 days before suspension, and reporting will be made mandatory in case of supply shortages.

Support will also be provided for the healthy social reintegration of drug addicts. Drug addicts identified through telephone counseling at the "Yonggihan Georeum Center" will be linked to receive rehabilitation support at the "Hamkkehan Georeum Center."

Regarding growth strategies, the "Regulatory Consistency Review" system will be fully implemented. Through this system, innovative product development research projects among national research and development projects will be selected to provide regulatory requirements, procedures, and commercialization strategies.

To cultivate regulatory science talent, theoretical and practical training courses at the level of the United States and the European Union (EU) will be operated, and participation in advanced overseas regulatory agency training aimed at enhancing capabilities such as risk assessment will be supported.

Cooperation with global regulatory agencies will also be pursued. The MFDS will act as an evaluation country for China's GMP (Good Manufacturing Practice) regulatory capacity assessment, which has applied for membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and plans to pursue additional registration in the World Health Organization (WHO) list of excellent regulatory agencies for pharmaceuticals.

In the innovation area, administrative efficiency will be focused on. A generative AI-based consultation service (tentatively named "Food Agent") that can provide 24-hour consultation on food labeling, standards and specifications, and business operator compliance will be operated, and "AI Cosbot," which provides domestic and international cosmetic regulatory information, will also be pilot operated.

Additionally, to innovate the new drug approval and review system, a dedicated review team will be established. Through this, specialized consultation services at each approval stage are expected to be provided. "Hurdle regulations" that hinder the development of future industries will be improved, and "livelihood-sensory regulations" that consider public vitality and marginalized groups will also be innovated.

Oh Yu-kyung, Commissioner of the MFDS, said, "We will focus on implementing the four core strategies in 2025 to establish a mature safety management system that firmly protects the safe daily lives of all citizens."

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