Approval Disparities for New Drugs in the US and Japan
Shingo Kasahara, Naohiko Wakutsu, Hiroshi Nakamura
TL;DR
This study compares how new drugs are approved in the US and Japan over 18 years.
Contribution
It identifies disparities in drug approval rates and timelines between the two countries.
Findings
The US approved drugs faster than Japan during the study period.
Certain therapeutic areas showed larger approval gaps between the two countries.
Regulatory differences may contribute to these disparities.
Abstract
This cross-sectional study evaluates drug approval disparities between the US and Japan from 2005 to 2022.
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Taxonomy
TopicsPharmaceutical Economics and Policy · Health Systems, Economic Evaluations, Quality of Life · Intellectual Property and Patents