Nehe City Rong Media Center
The reporter learned from the National Medical Insurance Administration that recently, DAEWOONG BIO INC. (Korea Daewoong Pharmaceutical) did not accept the overseas on-site dynamic inspection of cefdizime sodium for injection, a drug selected in the centralized procurement organized by the state, as required, and the State Food and Drug Administration judged the inspection as "not meeting the requirements", and took measures to suspend the import, sale and use of the product, and issued an announcement. The announcement is as follows: The results of the eighth batch of state-organized centralized drug procurement have been implemented in various places in July 2023. DAEWOONG BIO INC. failed to accept the overseas on-site dynamic inspection of the selected drug cefdizime sodium for injection as required, in violation of the Drug Administration Law of the People's Republic of China and the Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices, and the State Food and Drug Administration judged the inspection as "not meeting the requirements". On July 18, 2024, the National Medical Products Administration issued an announcement to suspend the import, sale and use of the product. In accordance with the spirit of the "Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of Centralized Drug Procurement Work" (Guo Ban Fa [2021] No. 2), after collective deliberation by the relevant member units of the National Drug Joint Procurement Office, the company violated the commitments made in the application materials and violated the relevant provisions of the "National Drug Centralized Procurement Document (GY-YD2023-1)", and the Joint Procurement Office decided to cancel DAEWOONG BIO INC.'s qualification for cefodizime sodium for injection, and at the same time, the company will be included in the "violation list" and the company's application qualification to participate in the centralized drug procurement activities organized by the state from July 18, 2024 to January 17, 2026 will be suspended. Provinces with DAEWOONG BIO INC. as the main supplier of cefdizime sodium for injection shall initiate the substitution procedure in accordance with the relevant provisions of the National Centralized Drug Procurement Document (GY-YD2023-1), and the backup supplier shall become the main supplier and supply according to the selected price; When the backup supply enterprise cannot meet the supply demand, the province where it is located will start the supply process of supplementing the supply enterprise.
Source: Heilongjiang Daily
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