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China To Unveil New Edition Of Drug GMPs Early Next Year

This article was originally published in PharmAsia News

Executive Summary

China's State FDA will release a draft of the new edition of drug good manufacturing practices to solicit public feedback early next year. The revision focuses on GMP safety, effectiveness and controllable quality, emphasizing the soft aspects to allow better applicability and to remove ambiguity. The draft enforces stricter file management and defines concepts such as drug quality authorization person, design verification, change management and deviation handling. Except for clean-room drug production, standards for other drug manufacturing facilities remain unchanged. Compatible with the latest Drug Registration Regulation and Administrative Measures for Drug Recalls, the draft also enhances GMP links with drug registration and post-marketing supervision, so as to strengthen the relationship between supervision of drug production and registration. (Click here for more - Chinese Language)



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