Based on the results of the overseas non-site inspection, the National Medical Products Administration (NMPA) issued Announcement No. 67 on August 22, 2022, deciding to suspend the import, sale, and use of UCB Pharma S.A.'s Levetiracetam Injection Concentrate Solution (original import registration number: H20170341, specification: 5ml:500mg, brand name: Keppra).
After UCB Pharma S.A. completed the required corrective actions, they submitted an application and related corrective action report to the NMPA for the resumption of the import, sale, and use of the product. Following a technical evaluation, the NMPA confirmed that the issues identified during the overseas non-site inspection had been resolved.
In accordance with the "Drug Administration Law of the People's Republic of China" and the "Regulations on Overseas Inspections of Drugs and Medical Devices," the NMPA has decided to resume the import, sale, and use of Levetiracetam Injection Concentrate Solution (current registration number: National Drug Approval HJ20170341, specification: 5ml:500mg, brand name: Keppra) produced by UCB Pharma S.A. from June 4, 2024.
Upon the release of this announcement, the drug supervision and administration departments at drug importation ports will issue import clearance certificates for the product.