China NMPA Drug Inspection - Anhui Jiezhong Biochemical Co., Ltd. - Rehmannia glutinosa (raw Rehmannia glutinosa)

The National Medical Products Administration (NMPA) of China issued Announcement No. 46 of 2018 on June 22, 2018, detailing non-compliance across 10 batches of drugs from nine different pharmaceutical companies. This announcement followed testing conducted by five provincial drug testing institutions, including the Qinghai Provincial Institute for Food and Drug Control.

Key manufacturers identified for violations include Bozhou Jingwan Traditional Chinese Medicine Pieces Factory, Tonghua Xinghua Pharmaceutical Co., Ltd., Harbin No. 6 Traditional Chinese Medicine Factory Co., Ltd., Yichun Jinbei Pharmaceutical Co., Ltd., Anhui Jiezhong Biochemical Co., Ltd., Sichuan Tianfu Shenlong Traditional Chinese Medicine Pieces Co., Ltd., Jiuquan Peifeng Traditional Chinese Medicine Ecological Planting and Processing Co., Ltd., Yantai Juxian Pharmaceutical Co., Ltd., and Beijing Shengshilong Pharmaceutical Co., Ltd.

The main issues of non-compliance, assessed against the *Pharmacopoeia of the People's Republic of China*, varied by product. These included deficiencies in appearance, content determination, fill weight uniformity, dissolution rate, acid-insoluble ash, and total ash content.

In response, regulatory authorities implemented immediate control measures, such as sealing and seizing the affected drugs. The implicated companies were directed to cease sales and use, recall products, and undertake necessary rectifications. Furthermore, the NMPA mandated provincial drug regulatory authorities to launch investigations into these companies for illegal activities, referencing Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*. These investigations are to be completed within three months, with the findings made public.