Starting this year, the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service will simultaneously carry out procedures for medical device approval and new technology verification. Previously, medical devices had to undergo an evaluation for new medical technology after approval. This change will allow for immediate market entry without a separate evaluation.
From April, pharmaceutical manufacturers and importers must report to the ministry 180 days prior to the suspension of drug supply. To broaden treatment opportunities for patients and accelerate the approval of innovative new drugs, the ministry will establish a dedicated review team. This aims to reduce the new drug approval period from the existing 420 days to 295 days.
The Ministry of Food and Drug Safety announced the '2025 Major Policy Implementation Plan' on the 21st. Minister Oh Yoo-kyung noted, "In response to the rapidly changing social and technological environment, we focused on establishing safety policies that the public can feel and an efficient regulatory system," and emphasized, "The ministry will do its utmost to ensure a mature safety management system that firmly protects the safe daily lives of all citizens."
◇ Ban on self-prescribing of propofol… Focused inspections on illegal distribution of obesity medication
Starting in February, medical professionals will be prohibited from prescribing propofol to themselves. The Ministry will analyze big data such as prescription amounts and the number of prescriptions collected by the integrated management system for narcotics to selectively inspect medical institutions suspected of over-prescribing and duplicative prescribing. Additionally, monitoring of the handling of medical narcotics in veterinary hospitals will be strengthened.
From June, the scope of patients' medication history verification prior to prescriptions will expand gradually from 'fentanyl' to include 'methylphenidate (ADHD treatment)' and 'appetite suppressants.'
In addition, the epidemiological investigation of narcotics conducted at wastewater treatment facilities will expand to points where a large influx of narcotics is expected. Areas with high estimated usage based on the investigation results will focus on enforcement and prevention of illegal narcotics usage.
The Ministry plans to conduct concentrated inspections of the online and illegal distribution and sales, as well as false and exaggerated advertising, of popular obesity treatments like Wigobi and Maunza. The 'Hangover Relief Verification System' will be implemented this month, permitting hangover relief claims and advertisements only when scientific data from human application tests is available.
◇ Support for the healthy social reintegration of drug addicts
A program to support the social reintegration of drug addicts will also be implemented. Those identified through the 24-hour hotline (1342) at the Yonggi-Hanggeol Center can receive rehabilitation support at facilities like the Han-Ggeol Center. Collaboration with the prosecution will also expand participants in the 'Judicial-Treatment-Rehabilitation linkage' program.
A certification system for specialized counselors in drug prevention education and rehabilitation will be operated to improve the quality of counseling, and after rehabilitation, phone monitoring and consultations linked to pharmacies will be regularly conducted to support drug addicts' commitment to sobriety. Additionally, a foundation will be established for the operation of a 'Residential Rehabilitation Center (Hope-Hanggeol Center)' that closely manages counseling, rehabilitation, and job training to assist individuals until their social reintegration.
◇ Mandatory reporting for changes in drug supply… Introduction of essential medical devices by the state
A medical product supply chain will also be established to resolve supply instability issues such as the shortage of antipyretics and cold medications.
From April, the advance reporting timeframe for pharmaceutical manufacturers and importers regarding the suspension of manufacturing and supply will be moved up to '180 days before suspension,' and they will also be obligated to report in case of supply shortages. This aims to enable rapid predictions and preparations for drug supply.
In October, the plan is to introduce the 'National Essential Medical Devices' system to ensure stable supply of essential medical devices in medical settings. The ministry will disclose the status of medical devices undergoing clinical trials that are necessary for treating severe patients, explain the application procedures for usage, and further clarify them.
◇ Shortening the new drug approval review process
The new drug approval and review system will also change. The Ministry will establish a dedicated review team to provide specialized counseling services at each approval stage.
New drugs will undergo priority data review, Good Manufacturing Practices (GMP) audits, etc., aiming to shorten approval times from 420 days to 295 days. The ministry plans to increase the number of face-to-face counseling sessions and introduce a 'Rolling Review Process' where necessary supplementary documents will be reviewed first as they are provided.
The ministry also aims to increase the proportion of capable review personnel, such as doctors and pharmacists, from the current 31% to 70% over time. It will enhance training programs in the latest technology fields and implement phase-specific tailored education (basic, core, advanced) to enhance the expertise and regulatory capabilities of review personnel.
◇ Accelerating market entry for medical devices and innovative products
Until now, medical devices had to enter the market after undergoing medical device approval, new technology verification, and benefit evaluation. Starting this year, the procedures for medical device approval (Ministry) and new technology verification (Health Insurance Review and Assessment Service) will be carried out simultaneously, allowing for immediate market entry. After market entry, the evaluation of new medical technologies will be conducted.
Moreover, a clinical evaluation system at an international level will be introduced to comprehensively review clinical trials, experience, and literature to strengthen the safety of new technology medical devices. This system will apply from digital medical devices to all innovative medical devices.
The 'Digital Medical Products Act,' which establishes a regulatory support legislative framework for medical products employing digital technology, will take effect in January, supporting the commercialization of digital medical products with evaluations reflecting the characteristics of each product, personnel training, research and development, etc.
Starting in April, the 'Regulatory Compliance Review' system will be fully operated, selecting innovative product development research among national research and development projects and providing regulatory requirements, procedures, and product commercialization strategies. To support the development of new technologies such as genetic diagnostic technology and antibody-drug conjugates, the ministry will provide approval guidelines and implement a 'Guidance Program' that links pre-consultations for regulatory stages like clinical trials and approvals to fast-track reviews, promoting market entry for innovative products.