Quality and Affordability: South Korea's Generic Medicine Consumption Regulated by the MFDS's Stringent Bioequivalence
South Korea's high consumption of generic medicines is a function of its national health insurance system's drive for cost containment, balanced against rigorous regulatory oversight by the Ministry of Food and Drug Safety (MFDS). Generics must pass mandatory bioequivalence tests to ensure they are therapeutically interchangeable with the original product.
The National Health Insurance Service (NHIS) plays a critical role by negotiating pricing and determining the reimbursement coverage for generic drugs, creating a favorable environment for their prescription. This comprehensive system of quality validation and cost management ensures that effective, affordable treatments are widely available to the population.




