Announcement on Associated Review and Approval of Pharmaceutical Packaging Materials, Excipients, and Finished Drug Products (No. 134, 2016)

Local Title:总局关于药包材药用辅料与药品关联审评审批有关事项的公告（2016年第134号）
Country/Region:Chinese Mainland
Competent Authority: Former China Food and Drug Administration (CFDA)
Type:Notice
Status:In force
Release Date:2016-08-10
Implementation Date:2016-08-10

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ZH	Official	总局关于药包材药用辅料与药品关联审评审批有关事项的公告（2016年第134号）	Download

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总局关于药包材药用辅料与药品关联审评审批有关事项的公告（2016年第134号）

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On Aug 10, 2016, the former China Food and Drug Administration (CFDA) released the Associated Review & Approval of Pharmaceutical Excipients, Packaging Materials and Finished Drug Products (No. 134, 2016). Since then, manufacturers of pharmaceutical excipients and packaging materials are required to submit DMFs (Drug Master Files) to the regulator for format reviews. Upon submission of the drug registration application, excipients and packaging materials will undergo technical reviews along with the associated finished drug products.