Zhang Y, Duan K
In early 2025 the Korean Ministry of Food and Drug Safety (MFDS) implemented a sweeping overhaul of its newdrug review systemintroducing dedicated review teams, expanding the number of sponsor consultations, allowing rolling review of CTD modules and conducting Good Manufacturing Practice (GMP) evaluations in parallel
The class of medications called GLP-1 drugs mimic a hormone in the bodys intestinal track to balance blood sugar levels and send the brain a signal that reduces hunger, which an increasing number of people have used to lose weight
While intriguing, these benefits lack robust clinical backing, and their consistency is uncertain
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Currently, Bellwether trials are expected to begin in late 2026 or early 2027, but these dates may change