Drug Discov Ther. 2007;1(1):12-13.

GMP implementation in China: A double-edged sword for the pharmaceutical industry.

Gai RY, Qu XJ, Lou HX, Han JX, Cui SX, Nakata M, Kokudo N, Sugawara Y, Kuroiwa C, Tang W


China’s Good Manufacturing Practice (GMP) standards that mainly parallel WHO standards were made compulsory in 2004. However, GMP implementation had both positive as well as negative impacts on the pharmaceutical industry, with negatives including pharmaceutical companies suffering economic hardships, poor execution of GMP standards, and sequent health scares. This report briefly describes the problems with GMP implementation in China.

KEYWORDS: GMP, pharmaceutical sector reform, policymaking, China

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