The bOPV Product of BIBP Successfully Passes On-Site Inspection by NAFDAC of Nigeria

Dr. Samson Adeyemi Fatoki and his colleague, inspectors from the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria, conducted a three-day on-site inspection of the Poliomyelitis (Live) Vaccine Type Ⅰ Type Ⅲ (Human Diploid Cell), Oral (bOPV) manufactured by Beijing Institute of Biological Products Co., Ltd. (BIBP), part of the China National Biotec Group Company Limited (CNBG). The inspection has recently been announced as successfully passed. Relevant personnel from CNBG Global Business Unit and China Sinopharm International Corporation participated in and supported the inspection process throughout.

During the inspection, the inspectors strictly followed Nigerian pharmaceutical regulations and internationally accepted standards, conducting a comprehensive and systematic technical assessment of key areas including the quality management system, production site management, laboratory controls, material traceability, and sterility assurance. Through in-depth document review and on-site investigation, the inspection team highly commended the operation of the quality management system and the standardized production processes at BIBP.

Nigeria is the most populous country in Africa. As one of the most influential pharmaceutical regulatory authorities on the continent, NAFDAC has achieved WHO Global Benchmarking Tool (GBT) maturity level 3 (ML3). Its inspection standards serve as an important benchmark within Africa and even the international pharmaceutical regulatory system. The successful completion of this on-site inspection represents another breakthrough in market access for the company's bOPV product in Africa, laying a solid foundation for further strengthening the public health footprint in the region. It also stands as a significant achievement in actively implementing China's national strategy for China-Africa cooperation and the high-quality development of the Belt and Road Initiative.

Looking ahead, BIBP will continue to fulfill its mission, contributing to global polio eradication efforts and public health initiatives in countries along the Belt and Road.