TY - JOUR
T1 - Transaction cost analysis of the new drug application process
T2 - A case study of a multinational pharmaceutical company in Japan
AU - Hamada, Shota
AU - Shibata, Akiko
AU - Urushihara, Hisashi
AU - Sengoku, Shintaro
AU - Suematsu, Chihiro
AU - Kawakami, Koji
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This study was supported by the Funding Program for Next Generation World-Leading Researchers from Japan’s Cabinet Office Council for Science and Technology Policy (S.S.).
PY - 2014/5
Y1 - 2014/5
N2 - 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.
AB - 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.
KW - Business analysis
KW - Drug development
KW - New drug application
KW - Regulatory affairs
KW - Transaction cost economics
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U2 - 10.1177/2168479013514235
DO - 10.1177/2168479013514235
M3 - Article
AN - SCOPUS:84905096862
SN - 2168-4790
VL - 48
SP - 371
EP - 377
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 3
ER -
