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China Releases Strictest Ever GMP Draft Guidelines; Laxer Standards Urged For Local Companies

This article was originally published in PharmAsia News

Executive Summary

SHANGHAI - China's State FDA recently published a new draft version of Good Manufacturing Practice guidelines for pharmaceuticals on its website for public comment

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SHANGHAI - China's State FDA released its long-awaited good manufacturing practices guidelines for pharmaceutical products Feb. 12, which will begin to be implemented in all new drug manufacturing sites in March

China Releases New Drug GMPs; Domestic Consolidation Expected To Accelerate

SHANGHAI - China's State FDA released its long-awaited good manufacturing practices guidelines for pharmaceutical products Feb. 12, which will begin to be implemented in all new drug manufacturing sites in March

China Releases New Drug GMPs; Domestic Consolidation Expected To Accelerate

Multinational pharmas operating in China will need to review their manufacturing practices comprehensively to ensure full compliance because China's GMP 2010 standards contain numerous unique requirements that are different from the U.S. and ICH/EU GMPs.

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