GC Biopharma announced on the 1st that the regular Good Manufacturing Practice (GMP) inspection by the World Health Organization (WHO) has been replaced by a written review.
This is the first time a domestic pharmaceutical company has replaced a WHO regular GMP inspection with a written review. The company noted, "Thanks to the international status enhancement of domestic regulatory agencies."
The Ministry of Food and Drug Safety joined the international GMP consortium in 2014 and was listed in the WHO's list of medicine regulatory agencies last year. This year, it was designated as the world's first for regulatory agencies in all fields of medicine and vaccines.
With the recognition of its regulatory capabilities at advanced country levels, domestic corporations have gained the benefits of written reviews instead of on-site inspections. This review will be applied to GC Biopharma's flu vaccine "GC Flu" and varicella vaccine "Varicella." The company expected a smooth pass, stating that it had all the necessary materials.
GC Biopharma expected that this simplification of procedures would save time and expense while increasing the reliability and brand value of Korean pharmaceuticals. Lee Jae-woo, head of the development division at GC Biopharma, said, "The written review is an achievement that combines the expansion of PQ certification and the strengthening of the Ministry's status," adding, "It will serve as a positive precedent for other domestic corporations."