GC Biopharma said Tuesday that it has obtained final approval from the World Health Organization (WHO) to replace its regular on-site Good Manufacturing Practice (GMP) inspection for WHO Prequalification (PQ) products with a desk assessment, a review process conducted every three years.
Following its inspection application in September last year, GC Biopharma secured WHO GMP compliance certification for its influenza vaccine GC Flu and varicella vaccine Varicella through a document-based review without an on-site visit.
GC Biopharma headquarters in Yongin, Gyeonggi Province (Courtesy of GC Biopharma)
According to the company, this marks the first case in Korea in which compliance with WHO GMP standards was recognized solely through a desk assessment, resulting in cost savings of more than 50 percent compared with conventional in-person inspections.
The achievement is widely viewed as reflecting the impact of the Ministry of Food and Drug Safety (MFDS) being listed as a WHO Listed Authority (WLA).
In 2025, the MFDS became the first regulatory authority in the world to be recognized by the WHO as a WLA across all functions in the pharmaceuticals and vaccines sector, officially demonstrating its global-level regulatory capabilities.
As a result, international procurement procedures for pharmaceuticals and vaccines are expected to proceed more efficiently, which is anticipated to have a positive impact on Korean companies’ expansion into the global procurement market.
Lee Jae-woo, head of the Development Department at GC Biopharma, said, “This approval following the written review is a testament to both GC Biopharma’s excellent quality management standards and the international regulatory credibility of the Ministry of Food and Drug Safety.” He added, “We will continue to do our utmost to ensure a stable supply of vaccines based on a quality system that meets global standards.”
Kim Ji-hye
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