Development Status and Issues Around Regenerative Medical Products in Japan: A Joint Questionnaire Survey of EFPIA Japan and PhRMA Japan

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  • SUZUKI Masayuki
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会 ノバルティス ファーマ株式会社 臨床開発統括部
  • IKEDA Akiko
    米国研究製薬工業協会 (PhRMA Japan) 薬事部会
  • ITO Takahisa
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会
  • OHFUJI Kazumi
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会
  • GOTO Yoshihide
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会
  • SUEMATSU Morio
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会
  • TERAO Yasuko
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会
  • YAMAGUCHI Yoriko
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会
  • HAYATA Satoru
    欧州製薬団体連合会 (EFPIA Japan) バイオ医薬品部会

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Other Title
  • 外資系企業における再生医療等製品の国内導入状況と諸問題—EFPIA JapanおよびPhRMA Japan加盟会社を対象としたアンケート調査から—
  • 外資系企業における再生医療等製品の国内導入状況と諸問題 : EFPIA JapanおよびPhRMA Japan加盟会社を対象としたアンケート調査から
  • ガイシケイ キギョウ ニ オケル サイセイ イリョウ トウ セイヒン ノ コクナイ ドウニュウ ジョウキョウ ト ショ モンダイ : EFPIA Japan オヨビ PhRMA Japan カメイ ガイシャ オ タイショウ ト シタ アンケート チョウサ カラ

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Abstract

<p>EFPIA Japan and PhRMA Japan conducted a joint questionnaire survey for development of regenerative medical products. In November 2014, regenerative medical products were newly defined by the Pharmaceutical and Medical Device Act, and conditional/time-limited approval system was also legislated in Japan leading the world. This new legislation, however, does not seem to direct foreign-affiliated pharmaceutical companies to proactively engage into development activities in Japan. For that reason, this joint survey was planned to understand the present situation of introduction for regenerative medical products from Headquarters and also to find issues and/or concerns on development in Japan. Twenty nine out of thirty three EFPIA Japan or PhRMA Japan member companies responded on this survey (88% on response rate). Fourteen companies (48%) had regenerative medical products in Headquarters. Total number of under development or launched products were 31, and 12 out of them were introduced or planned to introduce into Japan. The detailed investigation revealed a large development gap especially for the products which had already begun clinical trial in Headquarters. It implied a drug lag in future. Regarding issues and/or concerns to introduce the products into Japan, CMC and quality related matters were the most frequent, followed by domestic regulation like Cartagena law and uncertainty of business case.</p>

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