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【資料3】我が国の薬事制度に関する海外への情報発信について (14 ページ)

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出典情報 創薬力の強化・安定供給の確保等のための薬事規制のあり方に関する検討会(第5回 11/15)《厚生労働省》
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ジャパン・ヘルスケアベンチャー・サミット2023での「医療系ベンチャー育
成支援プログラム」活動紹介

Clinical research core hospital
(tentative)

◆ SUMMARY
Purpose
As part of efforts to systematize medical facility functions, the Minister
of Health, Labour and Welfare approves individual hospitals
having capabilities of playing a core role in the implementation of
clinical research.
Roles
○Design a plan for a specified clinical research and conduct it
○Play a leading role in the implementation of a specified clinical
research in case where it is conducted in cooperation with another
hospital or clinic
○Provide another hospital or clinic with consultations on the
implementation of specified clinical researches and necessary
information, advice or another type of assistance

➢ Promoting advanced efforts toward creating innovative drugs, etc.,
in order to utilize the effects of the research base provided Clinical
research core hospitals, etc., throughout Japan.

Support Program for medical ventures
Establish venture support departments in 14 Clinical research core
hospitals
Provide R&D support and joint research to Medical ventures

<details>
✓ Medical evaluation
(clinical needs, advices based on medical practice, etc.)
✓ Support by academic research organization
(develop clinical trial protocol, consult on pharmaceutical
affairs, cooperate in conducting clinical trials and so on...)

◆ Guide

○Provide trainings on specified clinical researches

The number of approved
hospitals...15 Hospitals
(As of October 1,2023)

◆EFFORTS



Hokkaido University Hospital



Tohoku University Hospital





















Kyoto University Hospital

Osaka University Hospital

The University of Tokyo Hospital

Kobe University Hospital

National Cancer Center Hospital East
Chiba University Hospital

Okayama University Hospital





National Cancer Center Hospital
Kyushu University Hospital
Juntendo University Hospital
Nagasaki University Hospital

Nagoya University Hospital

Keio University Hospital

MEDISO(MEDical Innovation Support Office); https://mediso.mhlw.go.jp/medical/

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出展者名
Keio University Hospital
Nagoya University Hospital
Kyoto University Hospital
Osaka University Hospital
Kobe University Hospital
Okayama University Hospital
Kyushu University Hospital
Hokkaido University Hospital
Tohoku University Hospital
Chiba University Hospital
National Cancer Center Hospital East
National Cancer Center Hospital
The University of Tokyo Hospital
Juntendo University Hospital

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