China NMPA Drug Inspection - Jilin Hengjin Pharmaceutical Co., Ltd. - Nedaplatin for Injection

On October 29, 2020, the National Medical Products Administration (NMPA) released Announcement No. 73, identifying 18 batches of drugs from 11 pharmaceutical companies that failed to meet quality standards. Key companies involved include Guizhou Diyi Health Pharmaceutical, Ruiyang Pharmaceutical, Jilin Yizheng Pharmaceutical Group, and Yunnan Botanical Pharmaceutical, among others. Testing conducted by various regional institutes revealed significant quality failures. Major issues identified included improper chemical purity (excessive free salicylic acid), failure to meet disintegration time requirements, excessive microbial limits, and the presence of visible foreign matter in injections. Other violations involved poor solution clarity, excessive ash content in traditional medicines, and identification discrepancies in herbal products like Rhodiola rosea.

Operating under the regulatory framework of the Drug Administration Law of the People's Republic of China and the 2015 Chinese Pharmacopoeia, the NMPA has mandated immediate action. Affected enterprises must suspend the sale and use of these batches and initiate product recalls. Furthermore, the companies are required to conduct thorough investigations into the root causes of these failures and implement effective corrective measures. Provincial regulatory authorities have been directed to investigate potential illegal activities regarding the production of substandard drugs and must publicly disclose the results of these investigations to ensure consumer safety and industrial compliance.