KPBMA proposes 'drug shortages·API·AI new drug' budget

Reflecting on the industry's requests, such as supporting KRW 900 million to pharmas with drugs in short supply

Proposes to allocate KRW 2 billion worth of direct support to companies producing APIs…also proposes a supplementary budget of KRW 30 billion for AI-based new drugs

Amid both ruling and opposition parties discussing the allocation of a supplementary budget plan, the Korean pharmaceutical industry has begun requesting a supplementary budget for two key initiatives: the "Production Support Business for Drugs with Supply Instability" and the "Direct Support Business for the Production of Active Pharmaceutical Ingredients." In particular, the industry requested increased funding to train professionals and build infrastructure for AI-driven new drug development.

 

The industry proposes a supplementary allocation of approximately KRW 32.05 billion for this fiscal year alone.

 

On March 31, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) submitted a supplementary budget request to the National Assembly, which includes the budget for stabilizing the drug supply chain and supporting AI-developed new drugs.

 

Specifically, the Korean pharmaceutical industry is seeking KRW 900 million to support production companies managing supply instability and KRW 2 billion for direct support to companies producing active pharmaceutical ingredients.

 

For AI-developed new drugs, the proposal outlines KRW 150 million for education and promotional activities, KRW 17 billion for establishing an automated research facility aimed at discovering innovative new compounds, and KRW 12 billion for establishing a virtual AI new drug research center.

 

◆Reinstating a previously reduced budget of KRW 900 million for drugs in short supply=an allocated budget of KRW 900 million for production support of pharmaceuticals of supply instability is intended to support one additional pharmaceutical company to abolish the issue of drugs in short supply.

 

Although a large-scale pharmaceutical shortage has been resolved, the requested budget aims to prevent sporadic events of individual pharmaceutical shortages.

 

The budget is intended to overcome shortages of essential medications, including compounding acetaminophen, general cold remedies, as well as drugs for motion sickness, constipation, hypertension, and pediatric cold medications, to prevent further disruptions in patient care.

 

Initially, the budget for supporting supply was set at KRW 1.8 billion but was later cut by KRW 900 million.

 

The final allocation is set as KRW 900 million.

 

The KPBMA maintains that reinstating the reduced KRW by 900 million and potentially increasing it is necessary to add one designated pharmaceutical company and support facilities·equipment.

 

◆API Production Support=a KRW 2 billion budget increase has been requested to boost the domestic production of active pharmaceutical ingredients (APIs).

 

Requests have been made to allocate a budget to improve the self-sufficiency rate of domestically produced APIs.

 

Following the COVID-19 pandemic, the reliance on imported raw materials has risen significantly, raising concerns about potential disruptions in domestic drug production and supply.

 

The KPBMA insists that although the government has implemented preferential pricing for drugs using domestic raw materials, API manufacturers still report that the policy’s benefits have not been fully realized.

 

The KPBMA calls for budget allocations to support the expansion of core production facilities, maintenance of equipment, and workforce training.

 

Furthermore, a supplementary budget of KRW 2 billion is being proposed to establish a monitoring system for the stockpiling·statistical tracking of frequently used APIs.

 

◆Requesting supplementary budget of an additional KRW of 29.15 billion for AI new drug discovery=A supplementary budget proposal requests an additional 150 million AI new drug discovery related to AI-based new drug development education·promotion.

 

This budget aims to train interdisciplinary professionals for utilizing AI-based digital technology for new drug development.

 

This budget aims to train field-ready professionals who can be immediately deployed to new drug development using AI-based digital technology.

 

It is expected to support establishing and operating Korea’s only AI new drug development education platform (LAIDD), coupled with project-based problem-solving training.

 

Through top-tier project mentoring from leading experts across academia, industry, and research, the program aims to nurture professionals capable of addressing complex challenges in drug discovery.

 

Amid rapid digital transformation of the bio-health sector and accelerated progress in AI new drug development, demand for advanced IT-BT interdisciplinary talent has surged.

 

Because this area lacks comprehensive training programs, the KPBMA has proposed addressing this issue.

 

◆Building AI-automated Autonomous Data Lab (ADL)=The KPBMA has proposed a supplementary budget request of KRW 12 billion to establish and deploy an AI-automated new drug research center, Autonomous Data Lab (ADL), for this year.

 

The lab will be built to utilize AI agents with specialized expertise and proactive thinking in various new drug development fields, aiming to boost the efficiency of domestic new drug development.

 

The total project cost is set at KRW 51 billion, to be allocated KRW 17 billion for stage 1 this year, KRW 17 billion for stage 2 in 2026, and KRW 17 billion for stage 3 in 2027.

 

The budget reflects on the synthesis process for candidate compounds with enhanced pharmacological properties in early-stage drug development.

 

Synthesis process is a high-cost and high-value-added area.

 

Recent advances in AI have enabled the development of synthesis design and optimization technologies, which have further evolved into autonomous laboratory systems when combined with robotics.

 

The proposal aims to promote the domestic adoption of these technologies.

 

◆A virtual AI new drug research center=The KPBMA has proposed a supplementary budget request of KRW 12 billion to establish and deploy a virtual AI new drug research center.

 

This center will use AI agents with specialized expertise and proactive thinking in various new drug development fields, aiming to boost the efficiency of domestic new drug development.

 

The total project cost is set at KRW 36 billion, to be allocated over three years from this year through 2027.

 

The KPBMA proposed that while adopting AI technology is essential for enhancing Korea’s new drug development competitiveness, there remains a shortage of AI experts with the specialized knowledge required for drug research.

 

The KPBMA states that technological advancement allows AI to conduct new drug research independently without additional staffing.

 

Thus, establishing a virtual AI new drug research center that can be integrated throughout the entire drug development process may be needed.