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Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At Japan (Part 5)

This article was originally published in PharmAsia News

Executive Summary

The one Asian country with "first-tier" status, Japan may be on a par with the U.S. and the EU in the International Conference on Harmonization, but the country nevertheless faces challenges in the CMC and GMP arenas, said Pramod Kotwal of Merck, Sharpe and Dohme

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