China’s Center for Drug Evaluation at the National Medical Products Administration released draft guidelines of technical requirements for research and evaluation of chemical pharmaceuticals that have been approved overseas, but are not registered in China. The NMPA along with the China National IP Administration also published draft guidelines for drug patent disputes, outlining details to implement patent linkage.
A Pink Sheet article includes remarks from life sciences regulatory & compliance partner Katherine Wang (Shanghai).
Katherine explains that unlike the U.S. Hatch-Waxman Act, which guides how generic drug makers can challenge patent exclusivity, the China guidelines outline mechanisms for originators to defend their exclusivity, and may shape the competitive landscape in favor of generic companies in the future.
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