聚乙二醇化重组人粒细胞刺激因子注射液

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齐鲁制药进口生物制品未办检疫审批被海关罚款 近年来偷税、虚空发票、生产劣药问题频现
Xin Lang Zheng Quan· 2025-07-03 09:16
Core Viewpoint - The recent administrative penalty imposed on Qilu Pharmaceutical highlights the critical importance of compliance with import regulations for biological products related to public health safety [1][2] Group 1: Incident Details - Qilu Pharmaceutical was penalized by the Capital Airport Customs for failing to obtain necessary quarantine approval for imported biological products [1] - The incident originated from a shipment on February 13, 2025, which included 720 boxes of polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor injection, valued at $68,400 [1] - The customs identified the goods as biological products related to public health safety that were not managed under drug, veterinary drug, or medical device regulations [1] Group 2: Regulatory Implications - The penalty serves as a warning to pharmaceutical companies, especially those dealing with new or special biological products, to strictly adhere to import quarantine approval regulations [2] - The fine of RMB 41,750, while seemingly minor, underscores the serious nature of compliance in the public health sector [2] Group 3: Company Compliance History - Qilu Pharmaceutical has faced multiple compliance issues in recent years, including tax evasion by its subsidiary, Henan Qihe Pharmaceutical, amounting to RMB 22.8973 million [2] - In June 2024, another subsidiary, Anhui Huaxing Chemical, was penalized for producing substandard pesticides, resulting in a fine of RMB 15,000 [2] - In 2025, the company was also reported for issuing false invoices worth RMB 1.351 billion in collaboration with a service platform [2] Group 4: Industry Implications - The case of Qilu Pharmaceutical serves as a cautionary tale for the entire pharmaceutical industry, emphasizing the need for strict adherence to regulatory compliance and risk management in operations [2]