Last year, the number of prescription drugs (ETC) that received item approval fell below that of over-the-counter drugs (OTC) for the first time in 15 years.
According to the Ministry of Food and Drug Safety on the 6th, among the 1,132 completed pharmaceutical products approved or reported last year, 550 were prescription drugs, a 37.8% decrease from the previous year (884 products).
The number of approved and reported prescription drugs has continuously decreased over five years, dropping from 4,139 in 2019 to 2,525 in 2020, 1,542 in 2021, and 1,097 in 2022.
In contrast, the number of over-the-counter drugs increased to 582 last year, up by 166 (39.9%) from the previous year (416 products). This marks an increase for the second consecutive year since recording 354 products in 2022.
The number of approved prescription drugs falling below that of over-the-counter drugs is the first occurrence since the compilation began in 2009.
The decrease in approved and reported prescription drugs is attributed to measures implemented since 2021 to prevent an unregulated influx of generic medications by limiting the number of drugs that can receive item approval with the same manufacturing site and methods.
The Ministry of Food and Drug Safety has limited the number of drugs that can apply for item approval with the same biological equivalence (bioequivalence) tests or clinical trial data from unlimited to a maximum of four, including one product from which initial data is generated and three additional products that can apply for approval utilizing this data.