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BioPharmaceutical Europe

Faster European drug reviews

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Executive Summary

U.K.'s National Institute for Clinical Excellence announces plans to expedite reviews. NHS division is "in discussion with the Department of Health over proposals for a revised process allowing more rapid appraisal of important new drugs." The proposals were evaluated by NICE's board at a meeting Sept. 21. The European Medicines Agency has also proposed its new framework for Scientific Advice & Protocol Assessment, which "provides for earlier and greater involvement of internal assessors and external experts." Comments are due by Nov. 22. EMEA projects the new review procedure could reduce response time from 100 days to 70 days (1"The Pink Sheet" July 11, 2005, p. 26)...

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