Research on unintroduced new drugs in South Korea from 2011 to 2020: approaches to prioritization and strategy.

In recent years, with the experience of the COVID-19 pandemic, countries around the world have realized that improving patient access to new medicines can have a significant impact on public health and economic stability. The aim of this study was to identify new drugs that are urgently needed among those not yet available in South Korea from 2011 to 2020, and to develop strategies to improve access by analyzing the causes of delay. Through a 3-step screening process that included a literature review of new drugs, surveys of domestic clinicians and academics, and consideration of expedited review status by regulatory authorities, 34 out of 244 unreleased new drugs were prioritized for rapid introduction. Reasons for drug delays were investigated through inquiries to the marketing authorization holders of the prioritized drugs and interviews with experts on new drug introductions. Key considerations for market entry include exemption from bridging clinical trials, reimbursement listing, and maximum reimbursement price. For foreign developers without domestic subsidiaries, providing systematic support-such as clear information on Korea's regulatory standards and facilitating reliable partnership matching-could improve access to priority unintroduced new drugs. Based on the results of this study, we propose strategies to facilitate the introduction of priority new drugs in South Korea.