On Aug. 24, China National Medical Products Administration (NMPA) suspended the import, sale, and use of UCB Pharma S.A.’s Levetiracetam Concentrated Solution for Injection (Keppra), a drug for epilepsy treatment.

In a recent remote inspection of UCB’s manufacturing factory in Belgium, NMPA found that the labelled validity period of some batches of Levetiracetam was inconsistent with the one approved. NMPA concluded that the products did not comply with the pharmaceutical Good Manufacturing Practice (GMP). (Official Notice)

In response to the suspension, it is reported that UCB has recalled all involved batches of the products. The company is taking corrective measures to restore its supply to the Chinese market as soon as possible.

In 2020, UCB won the bidding to supply Levetiracetam Concentrated Solution for Injection in China’s third round of national volume-based procurement (VBP). Though the product’s one-year VBP procurement term ended, the suspension could influence some provinces that have renewed the procurement contract with UCB.

More Companies Failing to Pass Drug Inspections in China

UCB is not the only company to be found with regulatory incompliance. In June 2020, Sun Pharmaceutical Industries, headquartered in India, failed to pass the sample inspection by Shanghai Institute for Food and Drug Control. The company’s Bicalutamide Tablets, a bid-winning product in the 5^th national VBP, did not meet the imported drug registration standards in terms of “loss on drying”. Due to the incompliance, Sun Pharmaceutical Industries was disqualified from supplying for VBP. The involved products were required to be suspended and recalled. (Official Notice)

China is stringent about drug inspections to ensure drug safety and quality. In 2021, China Center for Food and Drug Inspection (CFDI) completed 1,368 drug inspections, including 6 overseas inspections. (Official Notice)  It’s mandatory for companies to keep compliant with current regulations.

Contact BaiPharm for regulatory consulting service and GSP/GMP/pharmacovigilance audits.

[Read more at ChemLinked]

Reference Links

• China Announces Final Result of the 7th Volume-based Procurement (VBP) for Drugs
• 327 Drug Products to Enter China’s 7th Round of Volume-based Procurement (VBP)
• China CFDI Issues Drug Inspections Work Report in 2021

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