Govn’t seeks to upgrade 'Overseas AE safety monitoring network’

MFDS to strengthen administrative response in respone to the increase in emergency imports of essential medicines through the Korea Orphan & Essential Drug Center

Advisory process involving medical and pharmaceutical experts to assess overseas safety issues to be established

Analyzes regulatory practices of developed nations to determine the scale of dedicated personnel and resources

The Korean government plans to strengthen Korea’s national and public support policies to resolve frequent drug shortages caused by production or supply discontinuation from poor profitability. At the same time, it intends to modernize the system for collecting overseas safety information on imported medicines through the Korea Orphan & Essential Drug Center (KODC).

As the government expands administrative measures that provide essential medicines not supplied or manufactured by domestic private pharmaceutical companies through the KODC, it aims to ensure that information regarding adverse events and side effects associated with overseas medicines can be identified and addressed more rapidly and accurately.

On May 31, the Ministry of Food and Drug Safety (MFDS) announced plans to establish a system for collecting safety information and building a database for medicines supplied through the KODC, while also securing a framework for analyzing and reviewing overseas drug safety information.

The MFDS will also assess the level of human and material resources required to build and operate a database covering overseas medicines imported through KODC.

In Korea, when the supply of a drug manufactured or imported by a private pharmaceutical company is discontinued, or when marketing authorization is withdrawn and no domestic alternative is available, the MFDS uses its emergency import program through the KODC to directly purchase and supply overseas medicines and support patient-specific imports for self-treatment purposes.

The Lee Jae-myung administration has been promoting policies to expand emergency-import medicines this year in order to address essential medicine supply disruptions and recurring shortages. As a result, the proportion of medicines supplied through public channels via the KODC is expected to continue to increase.

Accordingly, the need to establish a system for collecting, analyzing, and rapidly responding to overseas safety information on medicines distributed by the KODC has become increasingly important.

The MFDS will launch a policy research project to establish the scope and methodology for gathering information on medicines supplied through the KODC. The study will examine regulatory approvals, safety information, recalls, and sales suspensions from advanced regulatory agencies such as the US FDA, the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The ministry will also conduct research on creating a database capable of accumulating, managing, and utilizing overseas safety information, while developing a user-friendly system designed to maximize accessibility and practical use.

In addition, it plans to establish update cycles, standards, and data display methods to ensure rapid mutual sharing of overseas safety information and real-time incorporation of the latest safety updates.

To establish an advisory and review framework for overseas safety information, the MFDS will develop a process for collecting opinions from medical and pharmaceutical experts regarding whether the supply of a medicine should be continued when safety concerns arise.

The MFDS intends to define the requirements for expert consultation, develop standardized advisory forms incorporating those requirements, identify appropriate academic societies and organizations to participate, and establish formal consultation procedures.

In effect, Korea will be building a physician-pharmacist advisory panel system to enhance domestic responses when overseas drug safety issues emerge.

Based on the results of this consultation, a review process will be established to determine whether to continue supply, analyze potential measures such as the emergency introduction of alternative products or suspension of supply.

To identify the human and material resources necessary for these new responsibilities, the MFDS will analyze comparable overseas cases and assess its current staffing structure. It will then calculate the appropriate workforce size and personnel costs required for the new tasks and define the roles of individual staff members.

An MFDS official explained, “We need a process to collect and build a database of drug safety information originating from overseas regarding medicines supplied and supported by KODC, and to establish measures for gathering expert advice and taking action when issues arise. At the same time, we will identify the human and material resources necessary to carry out these functions.”