MFDS allocates KRW 812.2 billion for next year's budget plan

8.4%↑from this year

KRW 170.4 billion has been allocated to enhance safety and innovative growth in the pharma·biohealth sectors

The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) has announced that its budget for 2026 has been set at a total of KRW 812.2 billion, an increase of KRW 63.3 billion (8.4%) from this year's budget of KRW 748.9 billion.

 

This budget plan was focused on facilitating the smooth execution of the new government's national tasks and restructuring expenditure to ensure efficient financial management.

 

The 2026 MFDS budget plan includes four areas: enhancing safety and expanding the foundation for innovative growth in the pharmaceutical and bio-health sectors, strengthening customized safety support for food and medicine, considering the regulatory environment, creating a safe food and healthy dietary environment, and building a proactive food and drug safety management system for the future.

 

A total of KRW 170.4 billion has been allocated to enhance safety and expand the foundation for innovative growth in the pharmaceutical and biotech sectors.

 

The Fund for the Korea Orphan & Essential Drug Center will increase from KRW 4.5 billion this year to KRW 6.7 billion next year.

 

To resolve the unstable supply of rare and essential medicines, MFDS will strengthen the stable supply foundation by expanding contract manufacturing of discontinued products and the emergency import of self-administered medicines with minimal demand.

 

For supporting and building a management system, such as innovative medical devices, KRW 2 billion will be invested.

 

A newly allocated budget of KRW 15 billion will be invested next year to fund the rapid commercialization of AI-driven products.

 

MFDS will assist in the swift commercialization of promising AI-based products in the food and medical device sectors, thereby shortening Korean companies' development timelines and accelerating their market entry.

 

The budget for the Korean Association Against Drug Abuse has been increased from KRW 16.5 billion this year to KRW 17.1 billion next year.

 

A total of KRW 105.4 billion has been allocated for strengthening customized safety support for food and medicine, taking into account the regulatory environment.

 

With the biohealth industry continuing to grow and the demand for systematic regulatory support from industries with limited experience and expertise increasing, MFDS plans to expand regulatory support by building an integrated consultation platform and securing customized consultation personnel for advanced and next-generation biopharmaceuticals.

 

The budget for this will be significantly increased from KRW 500 million this year to KRW 11.4 billion next year.

 

To lead the development of the pharmaceutical industry, MFDS will create review guidelines for new technologies and concepts, such as AI-driven products, and establish review standards that consider the characteristics of advanced and next-generation biopharmaceuticals.

 

This will secure approval and review capabilities at the level of developed countries.

 

To counter non-tariff barriers, such as country-specific approval regulations that hinder the export of Korean pharmaceuticals, MFDS will operate export approval support hubs.

 

These hubs will analyze and provide case studies of approvals by product and offer regulatory consultations for export countries, thereby supporting the swift acquisition of overseas drug approvals.

 

A new budget of KRW 5.5 billion has been allocated for operating a regulatory science talent development program in which universities, industries, and research institutes participate.

 

The goal is to cultivate regulatory science professionals who can scientifically evaluate the safety of advanced bio-health products.

 

A total of KRW 187.1 billion has been allocated for creating a safe food and healthy dietary environment, and a total of KRW 146.9 billion has been allocated for building a food and drug safety management system for the future.

 

Next year, MFDS plans to build an automated drug approval and review system.

 

This system will verify submitted document requirements, handle repetitive and routine tasks, and generate data summaries and reports.

 

The system is intended to address the shortage of review personnel and expand patients' treatment opportunities through a faster drug approval process.

 

The automation system will be expanded from generic drugs next year to active pharmaceutical ingredients (APIs) in 2027 and new drugs in 2028.

 

To respond to the changing environment, such as online food distribution and the development of artificial intelligence, MFDS will establish an Information Strategy Plan (ISP) to build an "Integrated Food Safety Information Network." This network will consolidate 15 food-related information systems and automate public service and administrative tasks.

 

In addition, as the scope of narcotics investigations expands, MFDS will secure digital forensics personnel and equipment dedicated to investigating medicinal narcotics.

 

It will also broaden the synthesis of standard materials for new psychoactive substances and the evaluation of dependence on temporary narcotics.

 

MFDS stated, "Once the 2026 budget plan is finalized through the National Assembly's deliberation process, we will do our best to execute the new government's national tasks and key projects without delay and protect the health and safety of the public."