China Suspends UCB's Antiepileptic Drug, Keppra, from Import, Sale, and Use

by Grace Wang Aug 26, 2022

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 labeled validity period of some batches of Levetiracetam was inconsistent with the one as approved. NMPA concluded that the products did not comply with the pharmaceutical Good Manufacturing Practice (GMP).1

In response to the suspension, it is reported that UCB has recalled all involved batches of the products. The company is taking correction measures to restore its supply to the Chinese market as soon as possible.2

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.

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 5th 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.3

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.4 It's mandatory for companies to keep compliant with current regulations. Contact BaiPharm for regulatory consulting service and GSP/GMP/pharmacovigilance audits.

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Grace Wang
ChemLinked Regulatory Analyst
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