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.

ABSTRACT:

Background

The Korean regulatory authority has enacted legislation to expedite the new drug approval (NDA) process. However, the effectiveness of such efforts in reducing review time and drug approval delays between Korea and the USA/EU remains to be evaluated.

Methods

We investigated NDA trends in Korea from 2011 to 2020 using approval information from pharmaceutical companies. We compared the changes in the actual review duration according to active ingredient (chemical vs. biological), orphan status, therapeutic class, and NDA review process. We estimated the submission and approval gaps of new drugs between Korea and the US and EU across the study period.

Results

For 235 new drugs, the median NDA review time was 315 days, with a significant increase in the delay (

SUBMITTER: Choi H 

PROVIDER: S-EPMC10133380 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature