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China State FDA To Implement System For Drug Quality Authorization

This article was originally published in PharmAsia News

Executive Summary

China's State FDA will implement an authorization system to ensure drug quality standards and provide accountability in the pharmaceutical industry. According to SFDA's notice, pharmaceutical firms should authorize drug quality administrators to supervise and manage drug quality, as well as conduct internal audits to assure compliance to standards set for drug production and safety. The system is an effective measure to strengthen internal corporate quality management systems, define quality responsibilities and improve the industry's management standards. China will introduce the system in stages, beginning with pilots this year in companies that manufacture blood products, vaccines, injections and controlled drugs. (Click here for more - Chinese language)



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