China NMPA Drug Inspection - Yunnan Mingding Pharmaceutical Co., Ltd. - Polyporus umbellatus

The Yunnan Provincial Food and Drug Administration issued an announcement on June 26, 2018, detailing the results of its first-quarter 2018 drug quality supervision and sampling inspections. Conducted across the province, these inspections aimed to bolster drug quality oversight and safeguard public health. The regulatory framework for these assessments primarily involved adherence to the 2010 and 2015 editions of the Chinese Pharmacopoeia. The inspections identified numerous instances of substandard drugs from various manufacturers. Key companies cited include Yunnan Xianghui Pharmaceutical Co., Ltd., Dongchuan District Jingtian Traditional Chinese Medicine Slices Factory, Yunnan Jinfeng Pharmaceutical Co., Ltd., Kunming Guandu District Huaxu Medicinal Materials Business Department, Yunnan Lvsheng Traditional Chinese Medicine Development Co., Ltd., Anhui Meiyu Traditional Chinese Medicine Pieces Co., Ltd., and Xuanwei Zhenghe Traditional Chinese Medicine Pieces Co., Ltd. The main violations consistently involved drugs failing to meet specified quality criteria, particularly concerning their 'Properties,' 'Identification,' and general 'Inspection' requirements as outlined in the Pharmacopoeia. Significant findings also included cases where drugs were not produced by the indicated manufacturer, such as with products attributed to Yunnan Lvsheng and Anhui Meiyu. Furthermore, one company, Xuanwei Zhenghe Traditional Chinese Medicine Pieces Co., Ltd., was found to be dissolved, preventing verification of its product. While specific immediate actions for the companies are not detailed in this announcement, the publication of these unqualified drugs necessitates subsequent regulatory measures to address the deficiencies and ensure market compliance.