No. 2 MFDS official visits EuBiologics to encourage quality control efforts

Vice Minister of Food and Drug Safety Kim Yoo-mi visited EuBiologics's vaccine manufacturing site in Chuncheon, Gangwon Province, to inspect the site and check the quality control status.

EuBbiologics obtained the World Health Organization (WHO) Quality Certification (PQ) for its cholera vaccine in April. The WHO reviews and certifies the quality, safety, and efficacy of vaccines and malaria and tuberculosis drugs to supply vaccines to underdeveloped countries. Obtaining WHO PQ is necessary to bid for international tenders hosted by U.N. organizations, including UNICEF.

Vice Minister Kim examined the status of the WHO PQ certification project on-site and discussed policy support measures to secure the reliability of domestic vaccines and increase exports.

"Looking at the vaccine manufacturing site and quality control status, I could feel the global competitiveness of our vaccines," Kim said. "As PQ-certified vaccines are supplied to the world through the WHO on behalf of Korea, I hope that Korean manufacturers will continue to supply excellent biopharmaceuticals to the international community."

EuBiologics CEO Baik Yeong-ok said, "We could obtain PQ certification quickly as the WHO recognized the results of the Ministry of Food and Drug Safety (MFDS)’s GMP evaluation of EuBiologics, which is a mandatory part of the PQ certification process. We hope many companies will benefit from the MFDS's support in the future."

Since 2013, MFDS has established the “WHO Vaccine Certification Support Plan” and actively supports Korean vaccine manufacturers to win WHO PQ and enter overseas markets by providing customized technical advice, operating a council to resolve industry difficulties, and publishing and distributing the WHO PQ information book.

"This year, we will continue to implement the WHO PQ support project for domestic vaccine and biosimilar manufacturers," the ministry said. "We will continue to provide technical support for WHO PQ at the government level to help domestic biopharmaceutical manufacturers, including vaccines, become more competitive in the overseas drug procurement market."