South Korea Expedites Approvals of Innovative Devices, Drugs

Approval times for the sale of medical devices and pharmaceutical products in South Korea are expected to shorten significantly now that two new divisions established to expedite reviews are up and running.

The Expedited Review and Pre-Submission Consultation Divisions created by the National Institute of Food and Drug Safety Evaluation (NIFDS) will evaluate orphan drugs and other pharmaceuticals designed to treat severe health conditions, infectious diseases, and other pharmaceuticals and medical devices that are considered advanced or innovative. Under the new processes employed by the two divisions, such products can expect to half the time approval normally takes.