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EU GMP Guideline Revision To Impact Chinese Pharmaceutical Export

This article was originally published in PharmAsia News

Executive Summary

The European Union has revised its Good Manufacturing Practices guideline to include quality risk management, which will come into effect in July. Analysts note that relevant corporations in China should attach great importance to this development because quality risk management represents the domestic pharmaceutical industry's weakest link. The new demand may impact the export of pharmaceutical preparations as well as medical raw materials. An expert involved in setting China's New GMP Inspectional Guidelines says that the standards follow closely those of the U.S. FDA and EU; thus the guidelines can almost satisfy the new EU GMP requirements. (Click here for more - Chinese Language)
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