South Korea Moves to Expedite, Simplify Approvals of Vaccines, Orphan Drugs

To speed the import of key new biologic agents needed to combat public health emergencies, including vaccines to help the body develop immunity to the virus that causes COVID-19, South Korea is cutting the steps required for regulatory approval of the products.

The April announcement by the Ministry of Food and Drug Safety will permit drug manufacturers to export their products to South Korea without certificates from the country of origin. The move accompanies the establishment of a new legal framework designed to quicken the approval process for orphan drugs and other pharmaceuticals used to treat rare diseases and other health conditions. The new framework will permit pharmaceuticals manufacturers, in some instances, to submit the results of clinical studies made on their products outside of Korea instead of conducting new Phase III clinical trials.