Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020.

Despite recent legislative initiatives, the delay in the NDA review timeline has steadily increased over 10 years in Korea. Delays in orphan drugs reviews increased after the enactment of the 'Rare Disease Management Act' in 2016. Careful enforcement of relevant laws and supplementary actions is required to increase new drug accessibility.