China Releases New Drug GMPs; Domestic Consolidation Expected To Accelerate
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Pharmatech Associates Bikash Chatterjee And Chat Kwan On China's Shift To A Global Standard With New GMP Guidelines: An Interview With PharmAsia News
Headquartered in the San Francisco Bay Area, Pharmatech Associates provides business consulting services in the pharmaceutical, biotech and medical device manufacturing sectors. The company recently held two training programs on the new Chinese Good Manufacturing Practice guidelines in Shanghai. During its Dec. 11 training program, Bikash Chatterjee, the company's president and Chat Kwan, Pharmatech's China president, sat down with PharmAsia News' Shanghai bureau to talk about how the new Chinese GMP guidelines will affect the industry in China and abroad.
China Releases Strictest Ever GMP Draft Guidelines; Laxer Standards Urged For Local Companies
SHANGHAI - China's State FDA recently published a new draft version of Good Manufacturing Practice guidelines for pharmaceuticals on its website for public comment
China Implements New Quality System To Strengthen Drug Safety; Puts Legal Onus On Drug Quality Attorneys
SHANGHAI - China's State FDA launched a new quality system April 10 that requires companies to assign responsibility for drug manufacturing to a drug quality administrator. The move builds accountability into drug manufacturers' systems