SK Bioscience announced on Thursday that it has successfully completed the World Health Organization’s (WHO) triennial review for its Prequalification (PQ) certified vaccines. The assessment, conducted via document review, covered the company’s influenza vaccines SKYCellflu and SKYCellflu Quadrivalent, chickenpox vaccine Skyvaricella, and typhoid vaccine Skytiphy.
WHO PQ certification evaluates vaccine quality, safety, and efficacy to determine eligibility for procurement by international bodies. This certification enables distribution through organizations like United Nations Children’s Fund (UNICEF) and the Pan American Health Organization (PAHO).
While WHO PQ assessments typically involve on-site inspections of manufacturing facilities, the evaluation for vaccines produced at SK Bioscience’s Andong L HOUSE was completed solely through document review.
The WHO’s decision to confirm PQ compliance without an on-site visit underscores the high level of confidence in the Andong L HOUSE’s operational and quality control systems.
This streamlined assessment process reflects the growing international trust in South Korea’s pharmaceutical regulatory framework, particularly following the designation of the Ministry of Food and Drug Safety (MFDS) as a WHO-listed regulatory authority (WLA).
The WHO’s regulatory trust policy recognizes the capabilities of WLA-designated countries, allowing for document-based reviews in lieu of on-site inspections in certain cases, based on MFDS’s PQ management results and evaluation materials.
Throughout the assessment, the MFDS facilitated the process by ensuring smooth submission of WHO-requested documents. This enabled SK Bioscience to maintain PQ compliance certification meeting international standards while optimizing resources compared to an on-site inspection.
SK Bioscience has consistently garnered recognition from major global regulatory bodies for its manufacturing and quality control expertise. The Andong L HOUSE secured European Union (EU)-PQ certification in 2021 and has successfully passed PQ verifications from numerous global regulatory authorities and international organizations.
The company recently inked international supply agreements for its proprietary influenza vaccine, SKYCellflu, further solidifying its reputation for quality and supply reliability in the global market.
The successful completion of the WHO PQ document review is a testament to the international recognition of our operational capabilities and quality systems at the Andong L HOUSE, stated Lee Sang-yoon, SK Bioscience’s plant manager. It remains committed to continually enhancing the quality management systems to meet and exceed global standards.