Korea Revamps Drug Review Processes, Cuts Approval Timelines

Under the new drug approval innovation measures, Korea will cut the review and approval period of new drugs to 295 days from 420 days and increase the number of expert reviewers to enhance review capabilities.

Korea Bolsters Drug Review Capabilities, Speeds Up Approval In Regulatory Innovation — Korea will Bolster its Drug Review Capabilities and Speed Approval times. • Source: Shutterstock

As part of ongoing efforts to grow the biohealth industry, Korea is revamping its drug approval processes and timelines to encourage new drug development on par with global norms.

Key Takeaways

The new drug approval innovation measures aim to match top global levels of new drug development through faster approval and stronger review capabilities.

The government aims to sharply raise the fees, while enhancing its expert review staff, but will exempt a portion of...