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PhRMA examining costs of converting NDAs to meet EU, Japanese requirements.

This article was originally published in The Tan Sheet

Executive Summary

PhRMA EXAMINING COSTS OF CONVERTING NDAs TO MEET EU AND JAPANESE STANDARDS to help justify its request for harmonized data submission requirements. In a May 9 letter to company regulatory affairs officials, the Pharmaceutical Research & Manufacturers of America noted that the International Conference on Harmonization steering committee has asked the association to conduct an industry survey in Japan, Europe and the U.S. "to quantify the resources, in terms of time and people, that are currently expended to rearrange, rewrite, reassemble, and otherwise customize a submission from one ICH region to another."
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