South Korea - Delays in overseas GMP Inspections
With the pandemic subsiding, the Ministry of Food and Drug Safety (MFDS) has resumed on-site inspections since 2023. However, due to the increased number of products subject to GMP on-site inspections and limited resources such as inspectors, scheduling delays have occurred, particularly for Chemical Products. Recently, some companies have been informed that GMP inspections for overseas manufacturing sites could be delayed by about 2-2.5 years after the initial application submission.
The delay in overseas GMP inspections could result in significant delays in the overall drug approval and variation process. This, in turn, could disrupt the supply chain and have a negative impact on importing products to the Korean market.
To address these challenges, the MFDS is working on recruiting more GMP inspectors dedicated to on-site inspections. However, it will take time for these measures to take effect.
Document Source