Announcement on Adjusting the Review and Approval of Active Pharmaceutical Ingredients, Pharmaceutical Excipients, and Packaging Materials (No. 146, 2017)

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Announcement on Adjusting the Review and Approval of Active Pharmaceutical Ingredients, Pharmaceutical Excipients, and Packaging Materials (No. 146, 2017)

Local Title:总局关于调整原料药、药用辅料和药包材审评审批事项的公告（2017年第146号）
Country/Region:Chinese Mainland
Competent Authority: Former China Food and Drug Administration (CFDA)
Type:Notice
Status:In force
Release Date:2017-11-30
Implementation Date:2017-11-30

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Language	Source	Title	Access
ZH	Official	总局关于调整原料药、药用辅料和药包材审评审批事项的公告（2017年第146号）	Download

Summary

On Nov. 30, 2017, the former China Food and Drug Administration (CFDA) started to require manufacturers of class 2.2/2.3/2.4/3/4/5 drugs' active pharmaceutical ingredients to file drug master files (DMFs). DMFs are also required for exipients and packaing materials of all classes of drugs. The filed DMFs enter the associated review together with the finished drug product's application.