The GMP process, which inspects the manufacturing facilities for pharmaceutical products, has been identified as a contributing factor to the delay in the approval of pharmaceuticals.

The Ministry of Food and Drug Safety (MFDS) has acknowledged the issue, but they have not yet addressed alternative solutions. Consequently, the bottleneck in GMP for global pharmaceuticals awaiting approval is worsening.

To gain approval for pharmaceuticals in Korea, pharmaceuticals undergo a series of evaluations, including safety and effectiveness evaluation, Good Manufacturing Practice (GMP) evaluation, and quality evaluation. Among these, the GMP evaluation examines the manufacturing facility of the ph