Approval Status and Regulatory Actions for Radiopharmaceuticals in the United States and Japan.

The aim of this study was to identify the differences between Japan and the United States in the approval status and regulatory actions for radiopharmaceuticals. The package inserts of radiopharmaceuticals that have been approved in the United States and Japan were used to investigate the status of approval in each country, examining the similarities and differences thereof and taking the regulatory systems of the 2 countries into account. Results revealed that since 1995, fewer products have been approved in Japan than in the United States: 16 radiopharmaceuticals have been approved in the United States, compared to only 7 in Japan.

Global development strategy for companion diagnostics based on the usage and approval history for biomarkers in Japan, the USA and the EU.

Aim: The aim of this study was to identify gaps between Japan and the West in biomarker usage and the development of companion diagnostics. We also elaborated potential scenarios for companion diagnostic development.

Methods: Information on drug labels in Japan, the USA and the EU was obtained from each regulatory authority's web site, as well as label information on in vitro diagnostic testing in Japan and the USA.