ABSTRACT
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. RESULTS: It is necessary to consider two factors when developing companion diagnostics globally: ethnic differences in gene mutations, and the approach to patient selection in clinical trials. A flowchart covering four scenarios was developed. CONCLUSION: Two factors that should be taken account when developing companion diagnostics globally was specified. This flowchart is expected to serve as a guide for streaming the development of companion diagnostics.
ABSTRACT
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. Although the clinical evaluation methodology for radiopharmaceuticals is still being developed, study results suggest that international harmonization of the regulatory systems and manufacturing controls for positron emission tomography drugs will be important for the development of such drugs in multinational countries, including Japan.
