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  • [Desk's View] Regulatory changes disrupt the generic mkt
  • by Chun, Seung-Hyun | translator Hong, Ji Yeon | Mar 5, 2025 06:00am
The strategies of Korean pharmaceutical companies for entering generic markets have significantly changed over the past few years. Pharmaceutical companies made entries and withdrawals indiscriminately because of the government's regulatory changes.

According to the Ministry of Food and Drug Safety (MFDS) report, prescriptions with approval declined by 35.6%, with 589 items. Compared to 4,195 counts in 2019, it shrunk by 86.0% over 4 years. The number of prescription drug approvals was 1,618 counts and 1,562 counts in 2017 and 2018, respectively. In 2019, it surged more than two-fold, with 4,195 counts. In 2020, it increased by 67.5% than two years before, with 2,616 counts. In 2021 and 2022, it decreased to 1,600
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