GC Biopharma said that the World Health Organization (WHO)’s regular good manufacturing practice reinspection for its prequalified vaccines will be conducted through a document-based paper review instead of an on-site visit, marking the first time a Korean drugmaker has taken this route.

The paper review, which replaces the routine inspection that recurs every three years, will assess GMP compliance for GC Biopharma’s WHO-prequalified influenza vaccine GCFLU and its varicella vaccine. The company said it has prepared the full documentation package and expects a smooth outcome.

GC Biopharma attributed the streamlined procedure to the rise in international standing of Korea’s national regulator.

The Ministry of Food and Drug Safety joined the Pharmaceutical Inspection Co-operation Scheme in 2014, was included on the WHO Listed Authority roster in 2023, and this year became the first authority recognized across the full scope of functions for both medicines and vaccines.

These milestones have enabled Korean manufacturers to benefit from reliance-based approaches such as desk audits in place of certain on-site inspections.

The company said the shift will cut time and costs while reinforcing the credibility and brand value of Made in Korea pharmaceuticals in global health markets. WHO prequalification is a widely used benchmark for quality, safety, and efficacy that guides procurement by United Nations agencies and other international buyers, and GMP compliance is a core pillar of that program.

“This paper review reflects both GC Biopharma’s expansion of WHO prequalified products and the strengthened international stature of the MFDS. We believe it will serve as a positive precedent for other Korean companies,” GC Biopharma’s Development Division Head Lee Jae-woo said.

GC Biopharma President and CEO Huh Eun-chul also said, “The company will continue to work with the WHO and the MFDS to broaden access to Korean vaccines in overseas tenders and immunization programs.”