20090518 EMEA guidelines: Osteoarthritis, chronic hepatitis C, Ankylosing Spondylitis

18/05/09 Clinical Investigation of Medicinal Products used in the Treatment of Osteoarthritis DRAFT
http://www.emea.europa.eu/pdfs/human/ewp/078497endraft.pdf

18/05/09 Guideline on the Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C
http://www.emea.europa.eu/pdfs/human/ewp/3003908enfin.pdf
See also Overview of comments
http://www.emea.europa.eu/pdfs/human/ewp/14496209en.pdf

18/05/09 Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis
http://www.emea.europa.eu/pdfs/human/ewp/489103enfin.pdf
See also Overview of comments
http://www.emea.europa.eu/pdfs/human/ewp/53700708en.pdf

20090518 EMEA Guideline on Missing data in confirmatory clinical trials Human Medicines

This guideline will replace the ‘Points to Consider on Missing Data in Clinical Trials’CPMP/EWP/1776/99.
とあります。

18/05/09 Guideline on Missing data in confirmatory clinical trials Human Medicines
http://www.emea.europa.eu/pdfs/human/ewp/177699endraft.pdf

20090512 EMEA Concept paper on the Development of a guideline on the use of Pharmacogenomics in the Pharmacokinetic Evaluation of medicinal products

20090430 MHLW 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 第一次提言

厚生労働省：厚生労働省関係審議会議事録等　その他（検討会、研究会等
医薬食品局
会議名 掲載案件名 開催日
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 第一次提言5月1日 09/04/30

http://www.mhlw.go.jp/shingi/2009/04/s0430-6.html
http://www.mhlw.go.jp/shingi/2009/04/dl/s0430-6a.pdf