[2027 Budget] Ministry of Food and Drug Safety Allocates KRW 882.9 Billion for 2027 to Support Global Expansion of Bio and Pharmaceutical Products

New Budget Allocated for Global Regulatory Support
CDMO-Specific GMP Guidelines and Certification Standards to Be Established
AI-Assisted Approval Review Expanded to Biopharmaceuticals

The Ministry of Food and Drug Safety will strengthen regulatory and licensing support in 2027 to facilitate the global expansion of bio and pharmaceutical products. New budgets will be allocated to support global pharmaceutical approvals and the quality certification of domestic biopharmaceutical raw and subsidiary materials, and a regulatory system specialized for the contract development and manufacturing (CDMO) industry will be established.

On September 1, the Ministry announced that its 2027 budget proposal has been set at KRW 882.9 billion, an increase of KRW 50.9 billion (6.1%) compared to this year’s KRW 832 billion. The Ministry will focus the budget on four key sectors: ▲creating safe and healthy food environments ▲digital and artificial intelligence (AI) transition of the food and drug safety system ▲strengthening global competitiveness of K-food and pharmaceuticals ▲and ensuring daily safety in food and drug sectors.

Of this, a total of KRW 175.2 billion will be allocated to enhancing the global competitiveness of K-food and pharmaceuticals. The budget for enhancing biopharmaceutical international competitiveness will rise from KRW 4.9 billion this year to KRW 5.8 billion next year. For technical support in global pharmaceutical approval review and regulation, KRW 4.8 billion has been newly allocated, while KRW 4.9 billion will be newly set aside for R&D to establish a quality certification system for domestic biopharmaceutical raw and subsidiary materials.

Regulatory support for biopharmaceutical CDMO will also be strengthened. In accordance with the enactment of the "Special Law on Regulatory Support for Contract Development and Manufacturing Organizations of Biopharmaceuticals," the Ministry will develop guidelines for GMP (Good Manufacturing Practice) certification and on-site application models reflecting the specific characteristics of CDMOs. Standards for the certification of biopharmaceutical raw materials will also be established to build a regulatory support framework at the governmental level.

The use of AI will be expanded in the pharmaceutical approval and review process. The license and review assistance system, currently being applied to generic drugs, will be extended to biopharmaceuticals and data-submitted pharmaceuticals next year. The Ministry plans to use AI for self-verification of submitted documents, automation of repetitive tasks, and summarization and translation of review materials, thereby improving the speed and efficiency of the approval and review process. This will be applied to new drugs starting from 2028.

A government-led system to adjust pharmaceutical supply and demand will also be newly introduced to address supply shortages. The government will stockpile periodically scarce pharmaceuticals during high-demand periods and supply them to the market in case of a shortage. An additional KRW 5 billion will be newly invested in R&D for the stable supply and productisation of essential medicines, and the support budget for the center for rare and essential medicines will be raised from KRW 7.5 billion to KRW 8 billion.

In the food safety sector, rapid agricultural product testing centers will be newly established in one location each in the Gyeongsang and Jeolla regions, in addition to the existing center in the greater Seoul area in Gimpo, to keep pace with the growth of online and overnight deliveries. The number of overseas direct purchase food inspections will be expanded to 10,000 cases, and on-site inspections of overseas food manufacturing facilities will increase from 200 cases this year to 400 next year.

The AI transition of the entire food and drug safety management infrastructure will also accelerate. KRW 11.5 billion, significantly more than this year's KRW 800 million, will be invested in integrating 16 types of food sector information systems based on AI. An additional KRW 4.6 billion will be allocated for establishing a system that integrates treatment and rehabilitation records of substance users and enables early identification of high-risk groups for relapse using AI.

A Ministry official stated, "If the budget plan is finalized following review and passage by the National Assembly, we will ensure successful implementation of major policies to safeguard public health and safety."

This content was produced with the assistance of AI translation services.