MFDS: "From the 21st, All Imported Pharmaceuticals Must Register 'Overseas Manufacturing Sites'"

[Asia Economy Reporter Lee Gwan-ju] The Ministry of Food and Drug Safety announced on the 18th that starting from the 21st of this month, it will fully implement a system requiring prior registration of overseas manufacturing sites for all pharmaceuticals intended for import.

The Ministry explained that this measure follows the expiration of the grace period on the 20th, which was granted for the implementation of the system expanding the registration requirement to include active pharmaceutical ingredients imported for the manufacture of finished pharmaceuticals.

The overseas manufacturing site registration system, implemented since December 2019, was established to enable prompt response to safety issues related to imported pharmaceuticals by registering information on personnel, facilities, and Good Manufacturing Practice (GMP) quality control of overseas manufacturing sites with the Ministry of Food and Drug Safety. The number of registered overseas manufacturing sites has steadily increased from 1,882 in 2020 to 2,208 in 2021, and 2,531 last year.

The Ministry stated, "We expect that the overseas manufacturing site registration system will enhance the reliability of the quality of imported pharmaceuticals and contribute to more thorough safety management," adding, "We will continue to do our best to ensure that the public can use high-quality pharmaceuticals with confidence through the safety management of imported pharmaceuticals."