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成川　衛

北里大学薬学部　臨床医学（医薬開発学）教授

薬剤師、博士（臨床統計学）

 

1991年3月に東京大学薬学部を卒業、同年4月に厚生省（現：厚生労働省）に入省。以後、主として新薬の臨床試験・承認審査、薬事政策、医薬品規制の国際調和（ICH）、薬価制度などに関連する業務に従事。途中1994年7月より半年間、米国食品医薬品局（FDA）医薬品評価研究センター（CDER）生物統計部にて客員研究員。2007年4月より北里大学薬学部准教授、2016年4月より現職。専門は、臨床試験、薬事 規制、生物統計学。

 

2007年5月から2010年12月まで総合科学技術会議 科学技術連携施策群 臨床研究・臨床への橋渡し研究連携群 主監補佐（非常勤）。2013年7月より一般財団法人 日本医薬情報センター（JAPIC）技術顧問（非常勤）。2016年4月より国立研究開発法人 日本医療研究開発機構（AMED）難治性疾患実用化研究事業プログラムオフィサー（非常勤）。
成川衛准教授写真

 

Dr. Mamoru Narukawa graduated from the Tokyo University, Faculty of Pharmaceutical Sciences, and joined the New Drugs Division, Ministry of Health and Welfare in 1991. Since then he has experienced several posts concerning new drug review/approval, pharmaceutical regulation and policy reforms, and medical insurance system including drug pricing. In the meantime, in 1994, he was temporarily transferred to the US Food and Drug Administration and spent half a year in the Division of Biostatistics in CDER. He had been a member of Expert Working Groups for several ICH Efficacy Topics from 1992 to 2000.

 

He became an Associate Professor in the Division of Pharmaceutical Medicine, Kitasato University Graduate School of Pharmaceutical Sciences in April 2007, and assumed the position of the Professor in April 2016. His specialties are clinical trials, pharmaceutical regulations, and biostatistics.

 

He worked as a Program Officer for Clinical & Translational Research in CSTP (Council for Science and Technology Policy), Coordination Program of Science and Technology Projects in Japan Science and Technology Agency (JST) from May 2007 to December 2010. He has been serving as a technical adviser to Japan Pharmaceutical Information Center (JAPIC) since July 2013, and a Program Officer for Practical Research Project for Rare/Intractable Diseases in AMED (Japan Agency for Medical Research and Development) since April 2016.