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fishbone · drug-filing · approval-delay

Factors Affecting Approval Time in Drug Filing

種類 特性要因図規格 Ishikawa (1968) cause-and-effectエンジン schematex-fishbone更新日 2026/6/26
Factors Affecting Approval Time in Drug Filing
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依頼内容

“Create a fishbone diagram for drug filing approval time exceeding target with personnel, process, technology, regulations, and data causes.”

次はこちらAdd reviewer capacity under Personnel.Change the effect to a delayed regulatory approval.
この図に含まれるもの

図の背後にある意思決定を読み解く。

01

Selecting relevant categories covering all aspects of the filing process

02

Prioritizing causes that directly impact timeline delays

03

Structuring the diagram to maintain clarity with indented sub-causes

This fishbone can be used in regulatory affairs improvement initiatives, root cause analysis meetings, and process optimization in drug development.

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