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  • GMP issues causing delays in new drug approval
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Jan 8, 2024 06:08am
The average waiting time per medicine is over 20 months.
A preliminary examination of drugs that are in high demand within society should be implemented.
 ¡ã The bottleneck in Good Manufacturing Practice (GMP) assessments is causing delays in the approval of global pharmaceuticals.
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 pharmaceuticals seeking ap
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