Transaction cost analysis of the new drug application process: A case study of a multinational pharmaceutical company in Japan

Shota Hamada, Akiko Shibata, Hisashi Urushihara, Shintaro Sengoku, Chihiro Suematsu, Koji Kawakami

研究成果: Article査読

抄録

The aim of this study was to measure the transaction costs of a new drug application (NDA) process in Japan in a case study of a multinational pharmaceutical company. The NDA process was viewed as involving transactions among 3 organizations: the headquarters, the Japanese subsidiary, and the Pharmaceuticals and Medical Devices Agency. Transaction costs were calculated by multiplying the time for each transaction by an hourly wage. Work time for the NDA process totaled 14,710.6 hours and was estimated to cost US$558,000 in human resource-related expenditure in the company. The total time for intracompany transactions was 7662.5 hours (52.1% of all transactions), which was similar to that of transactions with the Pharmaceuticals and Medical Devices Agency (7048.1 hours, 47.9%). Also found was a press-and-slack procedure in time course observation. In conclusion, the current NDA system in Japan imposes a considerable time and cost burden behind that of the visible official process on a multinational company.

本文言語English
ページ(範囲)371-377
ページ数7
ジャーナルTherapeutic Innovation and Regulatory Science
48
3
DOI
出版ステータスPublished - 2014 5
外部発表はい

ASJC Scopus subject areas

  • 薬理学、毒性学および薬学(その他)
  • 公衆衛生学、環境および労働衛生
  • 薬理学(医学)

フィンガープリント

「Transaction cost analysis of the new drug application process: A case study of a multinational pharmaceutical company in Japan」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル