1. Chinese regulators have disqualified more than 10 drug and medical-device companies from national bulk-procurement programs in 2025 after finding serious production or quality-management defects, highlighting safety concerns in a system designed to cut medical costs. [para. 1]
2. In the latest case, Shandong Beida Gaoke Huatai Pharmaceutical Co. had its production line for amiodarone hydrochloride injection suspended after regulators found serious deficiencies, including inadequate investigation of deviations and insufficient risk-control measures. [para. 2][para. 3]
3. The company lost its winning-bid status in the ninth round of centralized drug procurement and was placed on a "violation list," barred from participating in state-organized procurement from June 2026 to Dec. 2027. [para. 4]
4. Other companies stripped of winning-bid status include Harbin Liqiang Pharmaceutical (loxoprofen sodium gel patch), Chengdu Tiantaishan/Guangzhou Hehe (methocarbamol injection), and Weifang Zhongshi/Chongqing Derunsheng (formoterol fumarate inhalation solution). [para. 5]
5. In medical consumables, seven companies—including Hunan Weidekang Medical Technology and Shandong Zhushi Pharmaceutical—were found to have serious defects in quality-management systems for products such as ureteral access guidewires and balloon dilation catheters. [para. 6][para. 7]
6. According to China's 2014 guidelines, a serious defect is a significant departure from good manufacturing practice (GMP) that could cause harm. Professor Deng Yong noted that production deviations typically involve materials management, production processes, or quality control—such as insufficient ingredients, improper storage, or inaccurate testing. [para. 8][para. 9][para. 10]
7. The disclosed companies are mainly from the 11th round of drug procurement and the sixth round for medical consumables. Separately, among over 1,600 selected products from the first nine rounds, nine drugs were disqualified due to quality risks. [para. 11]
8. Repeated quality problems in generic drugs point to weaknesses in consistency evaluation and postmarket regulation. A former researcher said issues often lie in GMP compliance, with smaller Chinese drugmakers lacking discipline and lagging behind overseas and large domestic exporters. [para. 12][para. 13]
9. Another risk is that companies may alter production processes after approval to cut costs, exploiting weak enforcement. Postmarket changes are categorized as major, moderate, or minor; major changes must be filed with national regulators, while moderate and minor changes go to provincial regulators, leaving room for local protectionism. Some companies have switched to lower-cost processes or used contract research organizations to pass evaluations with processes unsuitable for large-scale manufacturing. [para. 14][para. 15][para. 16]
10. Since the 11th round in 2025, authorities have tightened quality controls, requiring selected drugs to be produced on GMP-compliant lines with no violations in the previous two years. New principles aim to "stabilize clinical use, ensure quality, oppose involution and prevent bid-rigging." [para. 17]
11. On June 23, China launched the 12th round of centralized drug procurement covering 65 products, adding three requirements: overseas generics must prove on-site or remote inspection by Chinese regulators; companies must pledge not to downgrade packaging; and selected drugs must undergo annual quality-review analysis. [para. 18][para. 19]
12. Li Jiangning, head of drug supervision at the National Medical Products Administration, said regulators are conducting full-coverage GMP sampling inspections of selected products, focusing on steeply cut-priced or difficult-to-manage drugs. So far, 490 products and more than 800 companies across the first 11 rounds have been inspected. [para. 20]
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