2010/01/18 第２０回薬害肝炎事件の検証及び再発防止のための医薬品行政のあり方検討委員会議事録

10/01/18 第２０回薬害肝炎事件の検証及び再発防止のための医薬品行政のあり方検討委員会議事録
http://www.mhlw.go.jp/shingi/2010/01/txt/s0118-11.txt

医薬食品局
薬害肝炎事件の検証及び再発防止のための医薬品行政のあり方検討委員会
http://www.mhlw.go.jp/shingi/other.html#iyaku

20100225 FDA guidance draft: Adaptive Design Clinical Trials for Drugs and Biologics

Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 424 KB)1 Clinical/Medical2 Draft 2/25/2010

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf

20100201 EMEA guidances: OA, RA

01/02/10 Guideline on Clinical Investigation of Medicinal Products used in the Treatment of Osteoarthritis
http://www.ema.europa.eu/pdfs/human/ewp/078497en.pdf

01/02/10 Overview of comments received on above draft guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis
http://www.ema.europa.eu/pdfs/human/ewp/81849609en.pdf

01/02/10 Concept paper on the need for revision of the points to consider on the Clinical Investigation of Medicinal Products other than Nsaids in Rheumatoid Arthritis
http://www.ema.europa.eu/pdfs/human/ewp/75155209en.pdf

20100210 EMEA guideline: Diabetes Melitus rev1; comments for draft BE guideline

10/02/10 Draft Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus
http://www.ema.europa.eu/pdfs/human/ewp/108000enrev1.pdf

10/02/10 Overview of comments received on draft guideline on the investigation of bioequivalence
http://www.ema.europa.eu/pdfs/human/ewp/2681710en.pdf

20100202 MHLW 医療情報システムの安全管理に関するガイドライン 第4.1版

医療情報ネットワーク基盤検討会
「医療情報システムの安全管理に関するガイドライン　第4.1版」に関するＱ＆Ａ
医療情報システムの安全管理に関するガイドライン　第4.1版
資料

http://www.mhlw.go.jp/shingi/2010/02/s0201-3.html
http://www.mhlw.go.jp/shingi/2010/02/s0202-4.html


審議会関係の資料が整理されて見やすくまとめられました
案件ごとに
回数 開催日 掲載案件名 議題等 議事録／議事要旨 資料等 開催案内
なってます

http://www.mhlw.go.jp/shingi/other.html

20100127 PMDA:Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response

Clinical Pharmacology & Therapeutics (2010); advance online publication 27 January 2010. doi:10.1038/clpt.2009.285

Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors
K Ichimaru1, S Toyoshima1 and Y Uyama1

1Office of New Drugs III, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

Correspondence: Y Uyama, (uyama-yoshiaki@pmda.go.jp)