'Drug efficacy classification number' reform has been initiated

Ministry of Food and Drug Safety (MFDS) has initiated comparative research to establish an ATC classification system comparable to a global standard, such as WHO

Domestic impacts on agencies, including the MOHW, HIRA, and FSS, will be surveyed after researching international cases, such as EMA

"Due to increased cases of difficulties in classifying efficacy and indications, improvements are necessary"

The South Korean government is initiating preliminary research to revise and modernize the domestic drug efficacy classification number system, which has remained largely unchanged since its establishment in the 1960s.

​Beginning with a comparative study against the global standard, the World Health Organization's (WHO) Anatomical Therapeutic Chemical (ATC) classification system, the government aims to enhance the international compatibility of the South Korean classification system and establish precise classification criteria aligned with drug efficacy and indications.

​On the 4th, the Ministry of Food and Drug Safety (MFDS) announced that it is initiating a comparative study between domestic drug classification numbers and WHO-ATC classification codes.

​The framework of the current domestic drug efficacy classification number system has been maintained without significant alteration since its introduction in the 1960s.

​Defined as a numerical structure under the MFDS administrative rule "Guidelines on Barcode Display and Management of Pharmaceuticals," the system assigns 3-digit or 4-digit numerical codes to classify all drugs authorized and distributed in Korea based on their therapeutic efficacy and intended use.

​The problem is criticism that the system, owing to its outdated origins and misalignment with global classification standards, fails to accurately reflect the diverse efficacy and mechanisms of action (MoAs) of modern therapeutics.

​Because its hierarchy is overly simplistic and lacks granular differentiation, accurately categorizing drugs by actual clinical efficacy remains difficult. Furthermore, persistent compatibility issues have been raised regarding international market expansion and data exchanges with overseas regulatory agencies.

​In response, the MFDS plans to overcome the limitations of the current framework and evaluate the feasibility of system improvements from multiple angles by conducting a comparative review against the globally utilized WHO-ATC classification system.

​First, the agency will investigate current labeling practices across major overseas regulatory authorities and assess the potential ripple effects on other domestic institutions, beginning with a comprehensive examination of how the WHO-ATC classification system is currently utilized domestically and internationally.

​The study will analyze overall regulatory systems where major overseas authorities, such as the European Medicines Agency (EMA), assign ATC codes to newly approved products and explicitly mandate them in drug labeling (package inserts).

​To analyze domestic impacts and cross-agency ramifications, the MFDS will survey the operational use of existing classification numbers across relevant organizations, including the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), and the Financial Supervisory Service (FSS), while evaluating the systemic and institutional effects of a transition to ATC codes from various perspectives. Additionally, the scope of HIRA's current operations related to ATC classification will be explicitly defined.

​Specific criteria and procedures will also be established to perform precise comparative analysis between existing drug classification numbers and ATC classification codes.

​The MFDS plans to minimize confusion in the field by systematizing mapping methodologies between legacy classification numbers and ATC codes, verifying data consistency, and conducting preliminary surveys on drugs that would be reclassified into different or entirely distinct categories compared to current listings.

​A standardization plan will be formulated to provide guidelines or assign preliminary in-house ATC classification codes for existing approved drugs or newly authorized products that have not yet been assigned official ATC codes.

​The MFDS intends to conduct this research through November of this year. The Pharmaceutical Approval Management Division has been appointed as the lead department.

​The MFDS explained, "The current drug efficacy classification number system was established in the 1960s and has been used for a long time without major updates," and added, "There have been some cases where proper classification by efficacy and indication is difficult due to incompatibility with international standards and a limited number of hierarchical levels. This is the rationale behind launching a comparative review with the internationally recognized WHO-ATC classification system."