AI to power Korea's next-gen drug safety system

The Korea Institute of Drug Safety and Risk Management (KIDS), the national drug safety agency, is set to overhaul Korea's drug surveillance system using AI and big data to move from manual oversight to real-time, predictive safety monitoring.

The agency on Tuesday unveiled a sweeping plan to automate adverse event reporting and digitize its patient compensation system, marking a key step toward the agency’s goal of "predictive pharmacovigilance."

“We will predict side effects based on AI and provide safety information to the public faster,” KIDS President Sohn Soo-jung said at a news conference on Tuesday, announcing a safety management innovation plan focused on "speed, communication, and performance."

The core of the innovation plan is to completely reorganize the reporting and analysis of adverse events, which were previously handled manually, into an automated system based on AI and large language models (LLMs).

In particular, the plan is to expand the standard data model (CDM) platform, which links electronic medical records (EMRs) of medical institutions nationwide, over three years from 2025, and to build an active surveillance system based on real-world data (RWD) in stages.

“We will increase the EMR-CDM network of 30 medical institutions to 66 institutions and link unstructured data to improve the accuracy of drug adverse event surveillance,” Sohn said. “We will also introduce LLM-based AI to review safety information to ensure speed and reliability in determining causality.”

These moves are in response to the surge in adverse event reports since the onset of the Covid-19 pandemic. Korea, the world's second-largest country for adverse event reporting to the World Health Organization-Uppsala Monitoring Center (WHO-UMC) in 2024, registers approximately 1.53 million data points per year; however, the existing manual analysis system is limited in both speed and quality.

The AI-powered transition covers not only adverse event monitoring but also the damage relief process.

KIDS will automate the process of submitting supporting documents, such as medical records and medication schedules, which are currently done manually, in conjunction with administrative agencies, and will gradually introduce an AI-based counseling platform starting in 2025.Patients will be able to access step-by-step guidance on the damage relief process through an AI-powered chatbot and complete their applications online.

The Drug Side Effect Damage Relief System has been in effect since 2014 as a national compensation system. It supports medical expenses, disability benefits, and funeral expenses with funds raised from contributions from pharmaceutical companies. However, due to the complexity of the application process and low awareness, the average payment rate has remained at 42 percent for the past five years.

“Victims of adverse drug reactions have suffered physical and mental damage from taking the drug itself,” Sohn said. “We will lower the threshold for application and improve the overall system to be more patient-centered so that it can lead to practical compensation.”

The existing paper and plastic “drug safety card” will also be converted to a mobile-based digital card. It will be equipped with a real-time warning function to prevent re-prescription of the same ingredient and will be available for immediate checking at frontline sites such as health centers.

KIDS will also raise awareness of the system. The budget for public relations for victim relief has been set at 82 million won ($58,960) for a period of 10 years. However, it has requested an increase in the budget from 2026 to the Ministry of Economy and Finance by establishing a public relations strategy utilizing TV and digital media.

The institute is also collaborating with overseas regulatory agencies, including the WHO and the Danish Medicines Agency, to share adverse event information internationally and expand the linkage base, ensuring that domestic surveillance data is reflected in the global system early.

"KIDS will become an integrated safety management hub that encompasses prevention, compensation, and education, not just a surveillance agency," Sohn said. "The goal is lifecycle safety management that people can experience."