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Chinese Province Implements Pilot Quality System To Strengthen Drug Safety

This article was originally published in PharmAsia News

Executive Summary

SHANGHAI - In the latest effort to strengthen drug safety measures in China, Guangdong province has taken a page out of the international quality systems playbook, launching a pilot system July 20 that assigns responsibility for drug manufacturing quality to a designated company official

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SHANGHAI - Following industry comments, China's State FDA released another draft GMP guideline for which it seeks additional public comments. The revised draft offers clarity on a few key points but still leaves huge gaps that will need to be filled slowly over time

SFDA Issues Revised GMP Draft Guideline Following Industry Comments; Expects Compliance To Come In Stages

SHANGHAI - Following industry comments, China's State FDA released another draft GMP guideline for which it seeks additional public comments. The revised draft offers clarity on a few key points but still leaves huge gaps that will need to be filled slowly over time

China's FDA Issues Revised GMP Draft Guideline Following Industry Comments; Expects Compliance To Come In Stages

"It will be interesting to see how much of a grace period is given for manufacturers to meet standards, or whether certain manufacturers will be 'grandfathered' under old rules," industry consultant says.

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