China NMPA Drug Inspection - Hubei Ruizhe Pharmaceutical Co., Ltd. - Ginkgo leaf medicine

The State Food and Drug Administration (SFDA) conducted a special supervision and sampling inspection of Ginkgo biloba-based medicines from September 6 to September 16, 2015. This third-phase inspection, organized with food and drug regulatory departments across 12 provinces, revealed significant non-compliance. Out of 185 previously identified unqualified batches, 125 tested positive for sophoridine, an unauthorized substance, using the SFDA's supplementary test method. This issue implicated 27 pharmaceutical companies, including Tianjin Yabao Pharmaceutical Technology and Jiangsu Chenpai Pharmaceutical Group. Companies are suspected of illegally adding sophoridine or utilizing adulterated Ginkgo biloba extract. Affected companies were required to implement recalls for substandard drugs. The SFDA mandated that by October 25th, implicated companies report the reasons and circumstances of non-compliance, detailing any illegal additions, quantities, batch numbers, and responsible personnel since January 1, 2015. Provincial food and drug administrations were tasked with summarizing these reports by October 30th and initiating investigations by November 10th to confirm illegal activities and identify responsible parties. Enterprises failing to comply with reporting requirements face severe penalties, with further enforcement guidelines expected from the SFDA.