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Analysis: Japan Drug System Encourages Moves Abroad

This article was originally published in PharmAsia News

Executive Summary

Oncolys BioPharma's experience with getting its Telomelysin carcinostatic drug through the U.S. FDA process highlights the legal and bureaucratic red tape of Japan's process, according to an analysis. The firm's president noted the U.S. FDA even advises a drug maker on which tests will not be needed while Japan has in place hurdles too high for small ventures to scale. There have been recent signs of change in Japan, but its domestic market is likely to continue to lag as Japanese drug makers move testing and sales elsewhere. (Click here for more - a subscription may be necessary



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