Biotech Values

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EMA plans to have capability to analyze raw data for MAA submission by the end of 2015 similar to what FDA had been doing for a long time

http://www.biocentury.com/dailynews/topstory/2013-03-14/ema-to-start-crunching-raw-data

Currently, companies provide an analysis of raw data in MAA submissions to EMA, and the agency then performs a risk-benefit analysis based on the company's analysis.