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Cancer drugs reached Korea one to two years after the United States, Europe and Japan between 2013 and 2022, mostly because companies applied later, not because the regulator was slow.
For cancer drugs approved between 2013 and 2022, the authors compared submission, approval and reimbursement timing in South Korea with the United States, the European Union and Japan, using multivariate linear and Cox regression. Korea showed an average delay of one to two years in submission and approval against the other three, but the Ministry of Food and Drug Safety's review time was much shorter than those lags and better than the European Medicines Agency's. Delays in reimbursement decisions were roughly halved over the period while the other lags lengthened, and the variation in approval delay was largely explained by submission delay.
For a Korean patient waiting for a drug already sold abroad, the wait is mostly decided by when the company chooses to apply, and then by the insurance decision, rather than by the regulator's review.
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