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Laboratory Inspection Support in China by Expanded Laboratory Management Solutions Case Study

A large biopharmaceutical company was running two Phase III trials for a novel Hepatitis B treatment. Their global studies included participants in China, and the company asked Covance to support their external laboratory testing for this cohort. This case study outlines the challenges the sponsor and laboratories faced in the inspection process with the China Food and Drug Administration (CFDA), which has since changed its name to the National Medical Products Administration (NMPA). The regulatory environment in China is considered to be highly challenging due to its lengthy approval process, which has historically caused a backlog of registration applications. While the review process has improved, sponsors are still required to keep up with evolving regulatory requirements. In addition, importing/exporting biological samples in China is a time-consuming, cumbersome process. Therefore, sponsors often rely on China-based CROs and laboratories to handle their in-country study testing.